January 8, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
GW Pharmaceuticals , a British biopharmaceutical company dedicated to developing therapeutics derived from marijuana, released news today pertaining to its first Phase III trial for cancer pain drug Sativex. The product was used as an adjunctive treatment to optimized chronic opioid therapy during experimentation. GW Pharmaceuticals and Otsuka Pharmaceutical Development & Commercialization, Inc., have announced that the drug did not meet its primary endpoint.
Additionally, Reuters reported that shares of GW Pharmaceuticals fell as much as 21 percent today. However, results from two additional Phase 3 studies are expected later this year, and their data could potentially allow the drug to be submitted for treating pain with advanced cancer.
“Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase II program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population”, said Justin Gover, CEO of GW Pharmaceuticals. “We have two additional pivotal Phase III trials ongoing which, if positive, would still allow us to submit a New Drug Application with the U.S. Food and Drug Administration. We look forward to results from these two further studies later this year.”
The primary efficacy measurement for the study was based on a 0-to-10 Numeric Rating Scale, which was analyzed using percent improvement from the baseline. The safety profile of Sativex had already been observed in previous studies, and it had been well tolerated in the past.
“We believe that cannabinoid therapy offers a potentially novel approach as a co-analgesic to provide pain relief beyond opioid therapy,” said Marie Fallon, principal investigator. “Too many patients with advanced cancer do not attain adequate pain relief from an opioid regimen, or experience unacceptable opioid side effects.”
Fast Track Designation for Sativex
Sativex, an investigational product, is composed of two cannabinoids: cannabidiol and delta 9 tetrahydrocannabinol. It is administered through an oromucosal spray, and its primary goal is to relieve cancer pain.
In April 2014, the drug received Fast Track Designation from the FDA. This designation is given to drugs that are intended to treat serious or life threatening conditions and address unmet medical needs.
“Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications,” Gover said at the time of the announcement. “We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn.”
