Benuvia Operations, an FDA registered, DEA licensed, and cGMP specializing in pharmaceutical cannabinoids, and the U.S. Department of Veterans Affairs Clinical Science Research and Development Service (VA CSRD) announced that the VA will conduct a Drug Clinical Trial with SYNDROS® (dronabinol) oral solution, CII. This will be a proof-of-concept trial of Cannabis Derivatives in Neuropathic Pain (CDNP) utilizing Benuvia's SYNDROS®, which is being provided along with placebo by Benuvia Operations, LLC. SYNDROS® is a fully-synthetic FDA-approved THC product with current indications, including Chemotherapy Induced Nausea and Vomiting (CINV) and Anorexia Associated Weight Loss and Aids (AAWLA).
A randomized, controlled, double blind trial is proposed to evaluate the efficacy and safety of Epidiolex®, Sativex®, and SYNDROS® in Veterans with chronic neuropathic pain. Veterans with diabetes are more likely than diabetic civilians to develop chronic disabling peripheral neuropathic pain (CDNP). Chronic neuropathic pain impairs Veterans more than civilians. Research on frontline treatments for CDNP shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabinoid derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabinoids for CDNP. Veterans are also likely to present with pain and pain-related polymorbidity significantly different from that of civilians, so a well-structured clinical trial of cannabinoids for Veterans with CDNP is vital. The study will enroll 320 participants over the next 3 years at 5 VA sites in the U.S. in a randomized phase II, 4-arm clinical trial.
"Our collaboration with the U.S. Department of Veterans Affairs represents a significant milestone in our commitment to advanced pharmaceutical research and development. We support our Veterans and hope to continue R&D with Benuvia's high-quality, cGMP certified leadership in small molecule pharmaceutical manufacturing and psychedelics. These products will potentially provide new beneficial FDA-approved medicines for both Veterans and patients suffering from unmet medical needs," said Terry Novak, CEO of Benuvia.