Postsurgical Pain Candidate Vocacapsaicin Demonstrates Efficacy in Reducing Opioid Use
In a presentation at the 2024 International Association for the Study of Pain World Congress, Concentric Analgesics shared positive Phase II data for its lead candidate.
Concentric Analgesics has shared positive Phase II data for its leading postsurgical pain management candidate, vocacapsaicin. The water-soluble prodrug displayed efficacy in reducing opioid use in patients following bunionectomy and total knee arthroplasty (TKA). Data were presented at the 2024 International Association for the Study of Pain World Congress.1
Vocacapsaicin is a water-soluble prodrug of capsaicin. It acts by releasing capsaicin at the surgical site after a single local administration during surgery. This triggers activation of the TRPV1 receptor on pain-specific nerves. The receptor then produces analgesia, which can last up to months without causing sensory side effects.
According to Concentric Analgesics, the separate trials for bunionectomy and TKA both showed the presence of durable analgesia that lasted for two weeks with reduced opioid usage and earlier opioid cessation. These results were deemed statistically significant.
In a press release, Harold Minkowitz, MD, president of Analgesics, Perioperative & Hospital Based Research at the HD Research LLC and an investigator in both studies said, “Vocacapsaicin is unlike anything on the market today, given its unique mechanism of action enabling long-lasting postsurgical analgesia. This distinct property allows for earlier cessation of opioids, an effect that has not been seen before with a single drug administration. If approved, vocacapsaicin will revolutionize post-operative pain management.”
For bunionectomy, all patients who received a dose of vocacapsaicin were able to stop their opioid medication by five days. In the placebo group, 16% still required opioids beyond the two-week study.
Following TKA, 50% of patients in the placebo group still required opioids compared to just 38% in the vocacapsaicin group after the same two-week timeframe.
In the same press release, Edwin Su, MD, attending orthopedic surgeon, Hospital for Special Surgery and professor of Orthopedic Surgery, Weill Cornell Medical College added, “The results of both studies are impressive. The TKA data is particularly important given that pain after joint replacement can last for weeks. The reduction in opioid consumption over two weeks was accompanied by earlier ambulation that will likely translate into earlier discharge, faster recovery and fewer callbacks. Vocacapsaicin has the potential to be an important addition to care pathways and meaningfully improve patient recovery after joint replacement.”
“In 2018, vocacapsaicin received Breakthrough Therapy Designation from the FDA for its effect on reducing opioid usage. The data from these two trials covering a variety of clinically meaningful opioid endpoints extend our understanding about the impact of vocacapsaicin on opioid reliance after surgery and have us well-positioned for Phase III trials and bringing a much needed innovative therapeutic to patients,” John Donovan, MD, founder and chief scientific officer at Concentric Analgesics said in the release.
In March 2022, Concentric Analgesics shared positive data of vocacapsaicin in open laparotomy for repair of abdominal ventral hernia. The Phase II pilot study conducted in 24 patients showed vocacapsaicin reduced pain after coughing by 46% compared to the placebo group during the first 96 hours after surgery. Additionally, pain with ambulation was reduced by 35%. These results were seen over the course of seven days.2
References
1. Concentric Analgesics Announces Data Highlighting Two Weeks of Durable Pain Relief and Earlier Cessation of Opioids in Two Surgical Procedures. News release. Concentric Analgesics. August 6, 2024. Accessed August 7, 2024. https://www.businesswire.com/news/home/20240805074824/en/Concentric-Analgesics-Announces-Data-Highlighting-Two-Weeks-of-Durable-Pain-Relief-and-Earlier-Cessation-of-Opioids-in-Two-Surgical-Procedures
2. Concentric Analgesics Announces Positive Results from Pilot Phase 2 Clinical Trial of Vocacapsaicin in Open Laparotomy for Repair of Abdominal Ventral Hernia. News release. Concentric Analgesics. March 30, 2022. Accessed August 7, 2024. https://www.concentricanalgesics.com/concentric-analgesics-announces-positive-results-from-pilot-phase-2-clinical-trial
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