Caliway Biopharmaceuticals announced that clinical results from the CBL-0202 phase 2 study of its novel localized fat reduction drug, CBL-514, have been accepted for publication in the Aesthetic Surgery Journal. This publication further validates the efficacy and safety of CBL-514 in localized fat reduction, highlighting its clinical value as an innovative non-surgical therapy. 

This follows the publication of the CBL-16001 phase 2a clinical results in the Aesthetic Surgery Journal in 2022.

Clinical results from the phase 2 CBL-0202 study revealed that eight weeks after the final treatment, over 60% of participants in the CBL-514 group achieved a reduction of at least 200mL of subcutaneous fat in the treated area, compared to 0% in the placebo group, achieving statistical significance (p< 0.0001).

Notably, 42.9% of these participants achieved at least a 150mL reduction in subcutaneous fat after only one treatment. Moreover, per-protocol analysis showed that participants experienced an average reduction of 28.1% of subcutaneous fat volume compared with placebo.

Fat Reduction Comparable to Liposuction

In comparison, according to a study published in the Aesthetic Surgery Journal in 2012, abdominal liposuction removed an average of 183mL of subcutaneous fat, indicating that CBL-514’s fat reduction efficacy could potentially surpass traditional liposuction. Additionally, the study demonstrated a favorable safety profile, with no severe adverse events reported.

Principal investigators emphasized that CBL-514 achieved a fat reduction effect comparable to liposuction, with significantly improved safety, shorter treatment duration, and no required downtime, “positioning CBL-514 as a promising alternative for non-invasive body contouring.”

“The acceptance of CBL-514’s phase 2 clinical data in ASJ once again affirms our research outcomes and capabilities, reinforcing CBL-514’s significant potential in the localized fat reduction market,” says Caliway’s CEO, Vivian Ling, in a release. “We will actively pursue further publications of CBL-0204 phase 2b results, to strengthen Caliway’s academic and commercial presence globally in the aesthetic medicine industry.”

Caliway will accelerate subject recruitment for two pivotal global phase 3 studies for localized fat reduction in Q3 2025, expanding international collaborations and steadily progressing toward the goal of developing an FDA-approved injectable drug for large-area localized fat reduction.

The study is expected to be officially published in Aesthetic Surgery Journal in Q2 2025.

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Q32 Bio Inc, a clinical-stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, announced additional results from part A of its SIGNAL-AA phase 2a clinical trial of bempikibart in patients with alopecia areata at the 2025 American Academy of Dermatology (AAD) Meeting in Orlando, Fla, demonstrating the investigational treatment leads to sustained hair regrowth.

Bempikibart is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking IL-7 and TSLP signaling that is in development for the treatment of alopecia areata and currently being evaluated in a phase 2 program.

“These findings demonstrate for the first time in patients the potential of an IL-7Rα antagonist approach to deliver durable and sustained activity and recapitulate over a decade of nonclinical research highlighting the potential of this type of sustained response in multiple animal disease models. Given these exciting findings, we have committed to advancing bempikibart as a potentially differentiated therapy for alopecia areata patients who have had limited treatment choices and, to date, no biologic option available,” says Jodie Morrison, chief executive officer of Q32 Bio, in a release. 

Results from SIGNAL-AA Part A Phase 2a Clinical Trial 

SIGNAL-AA Part A is a phase 2a, randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating bempikibart in adult patients with severe and very severe alopecia areata (baseline Severity of Alopecia Tool [SALT] scores of 50-100) treated over 24 weeks, with follow-up through 36 weeks. The trial is being conducted to evaluate the efficacy and safety of bempikibart 200 mg administered subcutaneously every other week compared to placebo. 

SIGNAL-AA part A comprised of 41 patients in the modified intent-to-treat population and 27 in the per protocol population, with a primary endpoint of the mean relative percent change in SALT score at 24 weeks compared with baseline, with follow-up in a 12-week post-treatment period through week 36. Additional data has been collected on patients after week 36, with follow-up on multiple patients through week 55 to date, and additional long-term follow-up ongoing.

Highlights on the per protocol basis from the 2025 AAD late-breaking presentation include: 

During the on-treatment window:

• At week 24: Patients with a SALT score of 50-100 treated with bempikibart (n=23) showed a mean reduction in SALT score of 16% vs a reduction of 2% in the placebo group (n=4). A Wilcoxon Rank Sum test yielded a p-value of 0.045.
• At week 26: Patients with severe and very severe disease treated with bempikibart showed a mean reduction in SALT score of 18% in the bempikibart group vs a reduction of 2% in the placebo group.
• At week 24: 9% of bempikibart patients with severe and very severe disease achieved a SALT score less than or equal to 20 compared to 0% in placebo.
• At week 26: 14% of bempikibart patients with severe and very severe disease achieved a SALT score less than or equal to 20 compared to 0% in placebo.
• In the subset of patients with severe disease (baseline SALT 50-95):
  • At week 24: patients treated with bempikibart (n=15) showed a mean reduction in SALT score of 25% improving to 27% at week 26.
  • At week 24: 13% of bempikibart patients achieved a achieved a SALT score less than or equal to 20, compared to 0% in placebo, improving to 21% at week 26 vs 0% in the placebo group.

“The responses of patients with longstanding and severe disease, not only at 24 weeks but several weeks after treatment withdrawal, is very provocative,” says Brett King, MD, PhD, of Dermatology Physicians of Connecticut and former associate professor of dermatology at Yale University School of Medicine, in a release. “If the activity of bempikibart, including the potential to induce a durable, long-term response, and the safety profile are confirmed in upcoming clinical trials, bempikibart has the potential to change the treatment paradigm of alopecia areata.”

During the post-treatment follow-up period:

Despite only 24 weeks of treatment across bempikibart treated patients, a deepening response, as measured by mean SALT improvement, was observed following dosing cessation (week 24) through the post-treatment follow-up period (week 36), a paradigm believed to be associated with IL-7 on-mechanism modulation of rebalancing T effector memory cells and T regulatory function.

• At week 36, across patients treated with bempikibart, a mean reduction in SALT score of 20% was observed. In the subset of patients with severe disease, at week 36, the mean reduction in SALT score was 28%.

Additional post-treatment data collection remains ongoing, including longer-term follow-up of patients following the completion of the trial (post 36 weeks). Outreach was made to patients regarding the post-treatment experience and patients willing to participate were re-consented.

• Amongst patients responding to outreach that completed the treatment period and showed a SALT response during the trial (n=12), all achieved maintenance of response or further hair growth in the post treatment period (post 24 weeks), including after the end of the trial (post 36 weeks).
  • All 12 were confirmed by SALT assessment by the investigator, with a median follow-up of 41 weeks to date (17 weeks post last treatment) with additional follow-up ongoing.
  • Of these, seven patients (7/12) showed additional hair growth by SALT assessment post-treatment, with median follow-up of 44 weeks to date (20 weeks post last treatment) with additional follow-up ongoing.
• At week 55: two patients demonstrated improved and ongoing responses approximately seven months following dosing cessation, supporting the potential for remittive effect and durability of response with bempikibart.

“In addition to the meaningful mean SALT reductions through week 24, we observed deepening responses throughout the follow-up period through week 36 and longer, despite dosing only through 24 weeks, including two patients with continued response at week 55, approximately seven months following dosing cessation,” says Jason Campagna, MD, PhD, chief medical officer of Q32 Bio, in a release. “Our development program for bempikibart is designed to expand on these results, first with our open-label extension allowing for longer-term dosing and follow-up, and second, with SIGNAL-AA part B which introduces a loading dosing regimen, longer dosing period and longer follow up. SIGNAL-AA part B is intended to support advancement into pivotal trials upon completion, pending review of the results.”

Bempikibart demonstrated a well-tolerated safety and tolerability profile, with no grade 3 or higher adverse events related to treatment. Further, no related viral infections were reported in the bempikibart group.

In addition, in the phase 2a clinical trial, bempikibart at 200mg subcutaneously every other week demonstrated favorable pharmacokinetics and target engagement as demonstrated by substantial reductions in biomarkers of Th2 and expected modulation of T-cells. 

Bempikibart Phase 2 Development Program

Q32 Bio is advancing a development program evaluating bempikibart in alopecia areata. Based on re-consent rates for continued follow-up and strong interest from SIGNAL-AA part A patients to re-initiate dosing, Q32 Bio plans to initiate an open-label extension following the same bempikibart dosing regimen leveraged in part A to enable longer-term follow-up of patients. 

Initiation remains on track for the first half of 2025.

In addition, Q32 Bio is advancing bempikibart in the part B portion of the SIGNAL-AA phase 2a clinical trial. SIGNAL-AA part B is an open-label clinical trial, dosing patients with bempikibart for 36 weeks, with follow-up out to 52 weeks, in approximately 20 evaluable patients with severe or very severe alopecia areata. Dosing will include an initial loading regimen of 200mg of bempikibart dosed weekly over four weeks, followed by a maintenance dose of 200mg every other week over a 32-week period for a total of 36 weeks. 

Efficacy will be evaluated on the basis of mean percentage change from baseline in SALT scores as well as the proportion of subjects achieving various relative and absolute SALT improvements at week 36, with follow-up through week 52. The trial is intended to support advancement into pivotal trials upon completion, pending review of the results. Q32 Bio expects to initiate part B in the first half of 2025 and report topline data in the first half of 2026.

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Further reading for you:

Key Takeaways

• Machine learning models can effectively predict the risk of persistent opioid use in hand surgery patients, particularly when using patient-reported data on factors like pain and mental health.
• The study found that having a preoperative opioid prescription is the strongest predictor of continued opioid use after surgery, highlighting the importance of individualized pain management strategies.
• These models could serve as decision-support tools to help clinicians identify high-risk patients and tailor pain management or counseling efforts to prevent opioid addiction.

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A machine learning algorithm performs well in predicting the risk of persistent opioid use after hand surgery, reports a study in the August issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

“We found that a machine learning model performs well in identifying hand surgery patients who are more likely to become persistent opioid users,” says ASPS Member Surgeon Kevin C. Chung, MD, MS, of the University of Michigan in Ann Arbor. “This may provide a more efficient strategy to identify high-risk patients and implement measures to prevent opioid addiction. Similarly, the use of artificial intelligence can facilitate a more personalized approach in prescribing the right pain medication in the optimal amount for a specific patient undergoing a particular operation.” 

Predicting Persistent Opioid Use 

The study evaluated two previously described machine learning models: one using patient-reported data from the Michigan Genomics Initiative (MGI) and one based on insurance claims data. The models were first evaluated in a large sample of general surgery patients, then in patients undergoing hand surgery, such as carpal tunnel or wrist fracture surgery. 

The study focused on whether the machine learning models could predict which patients would develop persistent opioid use, based on prescriptions filled up to six months after surgery. The MGI model included 889 patients, about half of whom had previous opioid use. The claims model was limited to 439 “opioid-naive” patients, without recent opioid use.  

In the MGI model, which included previous opioid users, 21% of patients developed persistent opioid use. In the insurance claims model, which excluded previous opioid users, 10% of patients had persistent opioid use. 

On “area under the curve” analysis, the MGI model performed very well in identifying patients with persistent opioid use: 84% in the model trained on hand surgery data and 85% in the general surgery population. By contrast, in the claims model, predictive ability was 69% based on hand surgery data and only 52% in the full data set. 

Assessing Postoperative Opioid Risk 

In the MGI model, having an opioid prescription before surgery was the strongest predictor of postoperative opioid use. Other predictive factors included overall body pain and prescription of hydrocodone—a relatively potent opioid that is commonly prescribed for postoperative pain. 

As in other types of surgery, persistent opioid use is a risk for patients undergoing hand surgery. Although some risk factors have been identified, assessing postoperative opioid risk is a challenging and time-consuming process given the diversity of the patient population and variation in complexity of procedures. The new study suggests that machine learning can provide a more integrated, straightforward approach to identifying high-risk patients. 

Models including patient-reported data on factors like pain and mental health—such as that collected in the MGI—appear to offer the highest predictive value. “With access to comprehensive datasets, machine learning has the potential to streamline the identification and analysis of detailed factors that influence patients’ postoperative pain experiences,” the researchers write. 

The authors note some limitations of their study, which may not reflect changes in prescribing patterns in response to the opioid epidemic. “In practice, these models could be implemented as decision-support tools to help clinicians efficiently identify patients who are most vulnerable to addiction and in need of tailored pain management or counseling,” Chung and his coauthors conclude.

That combination of declines means that the total amount of opioids dispensed to surgical patients in late 2022 was 66% lower compared with early 2016, according to the findings published in JAMA Network Open by a team from the University of Michigan (U-M) in Ann Arbor. But the rate of decline was much faster before the pandemic, the researchers report after comparing surgical opioid patterns before and after 2020. 

That’s even after they considered the unusual circumstances of spring 2020, when most elective surgery temporarily stopped to free up hospital capacity for COVID-19 patients and reduce unnecessary exposure to the SARS-CoV-2 virus. Even with the overall declines, American surgery patients in late 2022 still received the equivalent of 44 5-milligram pills of hydrocodone from pharmacies after their operations on average. That’s far higher than what patients need for most procedures.

“These data suggest surgical teams have substantially reduced opioid prescribing, but also suggest that efforts to right-size opioid prescriptions after surgery must continue,” says Kao-Ping Chua, MD, PhD, the senior author of the new study and an assistant professor of pediatrics at U-M. He worked with first author and former U-M research assistant Jason Zhang, who is now in medical school at Northwestern University.

Right-sizing Prescribing Opioids 

The authors note that surgeons should not strive to eliminate opioid prescribing altogether. “The goal should be to ensure that opioids are only prescribed when necessary, and that the amount of opioids prescribed matches the amount that patients need,” says Zhang. “Achieving these goals could help reduce the risk of opioid misuse, persistent opioid use, and diversion of pills to other people besides the patient.”

The potential for accidental exposure to opioids by others in the household, and interactions between opioids and other substances including alcohol and prescription drugs, are other reasons to focus on non-opioid surgical pain care.

Chua and colleagues have studied procedure-related opioid prescribing multiple times, including a recent study showing that the reduction in the rate of dental opioid prescribing has similarly slowed in recent years. They have worked with the Michigan Opioid Prescribing Engagement Network to develop prescribing guidelines for adult and pediatric surgical care available here.  

Surgical organizations and the Centers for Disease Control and Prevention have advised surgeons to rely less on opioid-based acute pain relief for their patients since the mid-2010s. But no studies have examined surgical opioid prescribing trends using pandemic-era data. The new study is based on data from a company called IQVIA that tracks prescriptions dispensed at 92% of U.S. pharmacies.

Research suggests that aesthetic medicine is experiencing an explosion in consumer adoption and is proving to be increasingly recession resilient. And as practitioners seek to meet the growing demand for aesthetic medical procedures, the company points out that practitioners need access to secure tools that comply with requirements for electronic prescribing for controlled substances (EPCS) and state prescription drug monitoring programs (PDMPs). To that end, the integration of DrFirst’s Rcopia in the BoomerangFX practice management workflows reportedly accelerates and streamlines the prescribing process while giving physicians access to medication history and drug interaction warnings to mitigate errors.

To promote better patient adherence to prescribed medications, BoomerangFX’s practice management and digital marketing software platform also will integrate DrFirst’s RxInform to automatically trigger a secure message to patients after their physician sends an electronic prescription to the pharmacy. From the RxInform message, patients can view their prescriptions, pharmacy location, educational materials, and savings options.

“We are thrilled to incorporate DrFirst’s medication management solutions into our industry-leading practice management platform,” said Jerome Dwight, CEO and co-founder of BoomerangFX. “At BoomerangFX, we’re constantly seeking innovative ways to bolster the performance and profitability of our clients. The integration of DrFirst’s medication management tools further bolsters our mission to serve as the foundational global platform for aesthetic medicine – healthcare is in need of digital transformation and many of our latest innovations in patient workflow automation, AI-driven digital marketing and retention marketing are designed to radically boost growth and transform a clinic’s operations.”

“We are pleased to partner with BoomerangFX,” said G. Cameron Deemer, CEO of DrFirst. “Clinicians need intelligent solutions for safe and efficient e-prescribing, as well as tools that help patients take their medications as prescribed.”

Dwight further commented, “BoomerangFX has been at the forefront of modernizing outdated clinic operations—many of our recent product releases continue to reshape this evolving industry—for example, our virtual digital assistant  ‘Auviya’ was the first of its kind to take the guesswork away from operational decision-making for clinic managers; our patient retention tools allows clinics to run fully automated intelligent patient acquisition campaigns; our email and text automation tools offer clinics ‘hands-free’ strategies to connect with prospective patient leads on platforms like Google and Facebook—ultimately our ongoing investments in Artificial Intelligence leveraging our cloud-based data lakes will allow us to bring radical changes to private healthcare practices globally.”

In 2022, BoomerangFX announced the launch of a fully integrated lead management dashboard inside a practice management system to allow clinic owners to monitor new patient leads and respond using a variety of automated and digital tools. 

The company’s cloud-based solutions for practice management, digital marketing and eLearning service clients across the USA, Canada, Australia with plans to expand into the United Kingdom, Asia and Latin America. 

The announcement comes on the heels of BoomerangFX’s recent partnership with Stripe for integrated point-of-sale payments globally.

STP705 Phase I Clinical Trial Results

This interim efficacy results reportedly examined efficacy data from six participants that were scheduled to undergo abdominoplasty. Each participant was treated with STP705 doses of 120 μg, 240 μg and 320 μg at volume per injection of either 0.5 ml or 1.0 ml per injection site as well as placebo consisting of normal saline. The test article administration area was the central to lower abdomen region designated for abdominoplasty and participants received a single injection per site up to three injections of test article approximately 28 days apart.

Participants in the safety review were examined for the presence of and severity of Local Skin Reactions (LSR) including erythema, edema, and bruising over a time frame as well as the incidence (severity and causality) of any adverse events for a time frame of approximately 98 days. Secondary analysis looked at histological evidence of fat changes that would be seen in fat tissue remodeling such as fat inflammation, panniculitis, fibrosis, and fat necrosis. Statistical analysis was performed with non-parametric one-way ANOVA using Kruskal-Wallis test and Dunn’s multiple comparison test.

The interim analysis results include data from six participants with 42 tissue samples in total. There were no significant adverse events and all tissue samples examined in this review using variables doses of STP705 showed histological evidence suggestive of fat remodeling. Based on the histological scoring and panniculitis + fat necrosis ranking, a dose-dependent effect was observed for all treatment groups comparing to the placebo group with statistical significance (P < 0.05). The 240 μg at the volume of 1.0 ml treatment group has demonstrated the most potent activity.

Commentary

Mark Nestor, MD, PhD, director of the Center for Clinical and Cosmetic Research and the Center for Cosmetic Enhancement, Aventura, Fla, a voluntary professor in the Division of Plastic Surgery at the University of Miami, Miller School of Medicine and the principal investigator (PI) of the Phase I clinical study commented, “The initial data from the Phase I trial appears to indicate that the use of STP705 in the treatment of unwanted fat is safe and shows clear signs of efficacy. Safety has been examined in the first of three subjects and histology of the injected areas post abdominoplasty has been evaluated. Regarding histology, there is a clear difference in many of the specimens between the placebo, and the subjects injected with STP705. We look forward to completing this first study and analyzing all the results in the near future.”

Michael Molyneaux, MD, executive director and chief medical officer at Sirnaomics, added, “Interim data from our clinical study of STP705 for fat reduction indicate that subjects that have received various doses of STP705 show clear histologic evidence of fat changes that would be observed in fat remodeling. The safety results were very encouraging with no systemic adverse events and no significant local skin or tissue changes. This finding is very important when selecting a product that will be used for non-surgical fat remodeling and the fact that there was clear histological evidence of fat remodeling in a dose dependent manner is very encouraging as we move into Phase II of the program. We anticipate final study report sometime in Q3 2023 after which time, we will request a meeting with the FDA to determine the path to approval for the program.”

This study is the Group’s first attempt to apply an RNAi therapeutic candidate for localized fat remodeling and Sirnaomics reportedly plans to use the information from this study to expand into the treatment of submental fat and other areas of noninvasive fat remodeling. According to the company, the positive interim results have better informed the Group about the later stage development of STP705 in the medical aesthetics category. The company adds that together with the positive results from STP705 for treatment of squamous cell carcinoma in situ (isSCC) and basal cell carcinoma (BCC), the Group has successfully leveraged the proof-of-concept human data from STP705. According to Sirnaomics, this advancement in fat remodeling is expected to open up a new therapeutic area of medical aesthetics for Sirnaomics’ pipeline and has received very positive responses from the market.

Results Encourage Further Work

“The interim results of this Phase I clinical study have brought a strong enthusiasm using RNAi drug for medical aesthetic treatment. This novel non-invasive fat-reduction option potentially offers millions of people with unwanted fat on their bodies, which are resistant to diet and exercise and influenced by aging and genetics, a unique way to address those all-too-common conditions,” said Patrick Lu, PhD, founder, chairman of the board, executive director, president and chief executive officer of Sirnaomics. “During our preclinical studies with a well-defined animal model, we found that STP705 demonstrated superior efficacy and safety, compared to a commercially available injection drug for the same indication. This observation encourages us not only to explore the utility of STP705 for medical aesthetics but also to advance it to become a best-in-class drug candidate for fat-remodeling.”

Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05422378.

According to the company, when delivered via a single IV injection, APONVIE reaches drug levels associated with ≥97% receptor occupancy in the brain within 5 minutes and maintains therapeutic plasma concentrations for at least 48 hours. The company describes APONVIE as a ready-to-use, easy to administer, innovative IV formulation that ensures rapid and consistent exposure in patients undergoing surgery. Treatment with aprepitant resulted in approximately 50% fewer patients vomiting in the first 24 and 48 hours compared to the current standard-of-care, IV ondansetron.

“There are approximately 36 million procedures in the U.S. each year involving patients with high to moderate risk for PONV, the patients who would benefit most from APONVIE. With superior efficacy and convenient dosing, APONVIE has the potential to reach several hundred million dollars in sales,” said Barry Quart, PharmD, chairman and chief executive officer of Heron. “This launch supports our ongoing commitment to delivering innovative solutions that improve the postoperative experience by addressing the two most common concerns after surgery, postoperative pain with ZYNRELEF and postoperative nausea and vomiting with APONVIE.”

“PONV is one of the most common and concerning side effects patients experience after surgery. Inadequately managed PONV can result in poor patient outcomes, decreased patient satisfaction as well as increased healthcare costs,” said Randy Robbins, MD, managing partner at Valiant Anesthesia Associates PLLC. “Aprepitant is proven to be the most effective single agent to prevent PONV based on a comprehensive Cochrane meta-analysis. The launch of APONVIE will now allow providers to prevent PONV without the limitations of the current oral route of administration. We are very excited to see that physicians can now offer patients a more convenient IV push that delivers aprepitant in a rapid, consistent, and reliable way with the same 48-hour duration of effect, providing a better experience for patients postoperatively.”

The article entitled, “Sufentanil sublingual tablet reduces postoperative opioid use following outpatient plastic surgery,” was published by the Aesthetic Surgery Journal Open Forum as an original article and was authored by Dr Hisham Seify from Newport Plastic Surgery in Newport Beach, Calif. The study was a retrospective chart review of patients (n=61) receiving a single 30 mcg SST 30 minutes prior to surgery (for shorter procedures) or 45 minutes prior to surgical extubation (longer procedures). A control group (n=32) underwent similar surgical procedures utilizing standard IV opioid treatment without SST. Outcome measures included PACU opioid use, adverse events, and recovery time compared to traditional IV opioid drug regimens. 

The demographics were similar between the two groups with over 90% of patients being female. Average age was 46.1 ± 13.4 in the SST group and 44.1 ± 9.6 in the control group. The most common surgical procedures performed in both groups were bilateral breast augmentations or reductions, often combined with an additional procedure (eg, liposuction and/or abdominoplasty). There was a trend for procedure duration to be slightly longer for controls (3 hours and 12 minutes) than for the SST group (2 hours and 40 minutes); (P=0.10). As a result, duration of surgery was used as a covariate for subsequent analyses comparing morphine milligram equivalent (MME) opioid administration between the SST and control groups.

Key findings from the study looking at the use of a single sufentanil sublingual tablet showed that 92% of SST patients received the dose prior to extubation due to the large proportion of lengthy cases that were performed. In addition, almost all control patients (90.6%) required rescue opioids during recovery in the PACU as compared to significantly fewer SST patients (16.4%); (P<0.001). While there was no difference in total intraoperative opioid administration between the groups, the average postoperative MME in the PACU was 3.60 ± 2.65 mg for the control group versus over 5-fold lower (0.64 ± 2.31 mg) for the SST group (P<0.001). Moreover, all patients received prophylactic antiemetics, however, 9.4% of patients in the control group required additional antiemetics due to nausea in the PACU, whereas only 1.6% of SST patients required an antiemetic in the PACU. Time to discharge was similar, being slightly under an hour in both groups, and not driven by assessment of pain management and/or adverse events. Instead, the actual discharge time was based on standard nursing routines and availability of patient transport.

Study limitations include that it was a chart review and not a prospectively designed, randomized study. In addition, no pain scores or readiness for discharge assessments were performed, which could have been used to assess the potential of sufentanil sublingual tablet to facilitate a timelier discharge.

“The vast majority of cosmetic surgical cases are outpatient procedures and patients who are having 3- to 4-hour surgeries must quickly recover in order to be discharged home,” said Dr Hisham Seify. “Replacing the last intraoperative dose of IV opioids with an equivalent dose of SST dramatically decreased the need for recovery opioids in the PACU, as shown by our study results. Since our PACU protocol was standardized, we didn’t observe a more rapid time to discharge in this retrospective study. However, based on these findings, we now know to have our nurses expedite the discharge paperwork for SST-treated patients and tell family members to be ready sooner to drive the patient home.” 

“Multiple perioperative studies have now been published demonstrating the ability of DSUVIA to dramatically reduce opioid requirements in the postoperative period compared to standard IV opioids,” stated Dr Pamela Palmer, AcelRx chief medical officer and co-founder. “Based on standard clinical guidelines, every time an IV opioid is administered in the PACU, the discharge clock is restarted. We also know that increased opioid administration increases the risk of nausea and vomiting, which is one of the top reasons for delayed post-surgical discharge. The adoption of DSUVIA is gaining momentum as physicians are seeing these documented clinical advantages.”

The company disclosed in its press release that Seify is a paid consultant for AcelRx and the company provided funding for the study as an investigator-initiated trial.

AcelRx Pharmaceuticals announced a summary of results from a podium presentation on Dsuvia (sufentanil sublingual tablet) presented at the annual meeting of The Aesthetic Society.

The podium presentation, Patient Experience and Opioid Minimalization in Outpatient Plastic Surgery Procedures Using a Sufentanil Sublingual Tablet, was presented by Hisham Seify, MD, PhD, FACS, a board-certified plastic surgeon, past-president of the Orange County Society of Plastic Surgeons, and Associate Clinical Professor at the David Geffen UCLA School of Medicine.

Some of the data presented at the meeting were from an investigator-initiated trial supported by AcelRx.

The data was collected from 124 patients during both waking cosmetic procedures and under general anesthesia.

All 92 SST-treated patients received a single SST administered either 30 minutes before shorter-duration procedures or 45 minutes before extubation for longer-duration procedures.

The 32 control patients all received general anesthesia with standard intravenous opioids.

The control group required significantly more IV morphine milligram equivalents (MME) during recovery than SST-treated patients for patients undergoing general anesthesia.

The average dose of opioids administered in the post-anesthesia care unit (PACU) to control patients was more than five-fold higher than SST-treated patients, with controls receiving 3.60 ± 2.65 MME as contrasted with SST-treated patients that were administered an average of 0.64 ± 2.31 MME (p <.001).

In surgery without general anesthesia, no SST-treated patients required opioids or other analgesics in the PACU for pain. The mean recovery time was under an hour for the general anesthesia SST-treated patients and only 15 minutes for the awake cosmetic SST-treated patients.

Adverse events requiring medical intervention following general anesthesia were minimal in SST-treated patients, with 1.6% requiring additional antiemetics in the PACU compared to 9.4% of control patients. In awake cosmetic patients, 3.2% of SST-treated patients required an antiemetic in the PACU to treat nausea.

“My extensive experience with operating on patients treated with Dsuvia has reinforced my earlier observations that Dsuvia is a unique sublingual alternative to IV opioids that can clearly enhance the standard of care in perioperative analgesia,” said Seify. “Administering a sublingual opioid to surgical patients that is well-tolerated, avoids the traditional peaks and troughs of IV administration, and substantially reduces the use of postoperative opioids, thereby facilitating a timely discharge, represents an exciting progression in the management of perioperative pain in the surgical setting.”

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The resubmission follows the company’s Type A meeting in December 2021 and the subsequent completion of the production of three consecutive drug substance lots and one drug product lot as part of the qualification of a new working cell bank (WCB), which was required by the FDA to address the outstanding observations related to the WCB and the drug substance manufacturing process.

In reporting the company’s Q4 2021 financial results, Revance CEO Mark J. Foley also provided an update on the company’s products, and when speaking about DaxibotulinumtoxinA for Injection said, “We remain focused on getting our neuromodulator approved as soon as possible and look forward to engaging with the agency to facilitate this process.”

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