Concentric AnalgesicsAnnounces Positive Results from Pilot Phase 2 Clinical Trial of Vocacapsaicin in Open Laparotomy for Repair of Abdominal Ventral Hernia
VocacapsaicinPain, PostoperativeBreakthrough TherapyFirst in Class
Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics, today announced positive results from its recently completed pilot Phase 2 clinical trial of vocacapsaicin in patients undergoing open laparotomy for ventral hernia repair. Vocacapsaicin is a first-in-class, non-opioid, long-lasting therapeutic with FDA Breakthrough Therapy Designation that is administered as a single dose during surgery. The primary objectives of the study, conducted in 24 patients, were to evaluate the effects of vocacapsaicin over 7 days on reported pain with activity, pain at rest, and opioid consumption, as well as safety and pharmacokinetics.
The pilot study showed that vocacapsaicin, administered during surgery at a dose of 24 mg (0.3 mg/mL solution), reduced pain after coughing by 46% compared to the placebo control during the first 96 hours after surgery (p=0.02). In addition, pain with ambulation was reduced by 35% (p=0.08). Similar positive trends were seen in the reduction of pain at rest and reduction of opioid consumption. Furthermore, these efficacy trends were still evident for 7 days following surgery. Vocacapsaicin generally appeared safe and well tolerated compared to the control group.
The company will present the detailed clinical data at the 47th Annual Regional Anesthesiology and Acute Pain Medicine (“ASRA”) Meeting on March 31, 2022, in Las Vegas, Nevada. The spring ASRA meeting is the premier meeting for regional anesthesia and pain medicine.
"I have been following the clinical progress of this impressive product candidate. The data from this abdominal surgery study, coupled with the prior positive results from total knee arthroplasty and bunionectomy surgery, suggest that vocacapsaicin may be efficacious in addressing pain following a variety of surgeries, including both soft tissue and orthopedic surgery,” said Alparslan Turan, M.D., Professor of Anesthesiology at Lerner College of Medicine of Case Western University and Vice Chair of the Department of Outcomes Research at the Cleveland Clinic, the largest single-center clinical research group in the field of anesthesiology. “The need for non-opioid pain medicine in the postsurgical setting cannot be overstated, and vocacapsaicin has the potential to fulfill that need.”
“Given the increased focus on reducing opioid consumption and accelerating mobilization following surgery, managing pain during activity has become a high priority for clinical care,” said Sam Teichman, M.D., Head of Clinical Development at Concentric Analgesics. “The results of this study provide an indication of the potential for vocacapsaicin to manage pain across a number of evaluated activity parameters, and also provide guidance for our open laparotomy pivotal study.”
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