GW SUBMITS APPLICATION FOR CANNABINOID CANCER PAIN DRUG

GW Pharmaceuticals and Bayer HealthCare have announced that GW has submitted an application in Canada for Sativex to seek approval for a new indication in the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.

This submission follows a formal presubmission meeting recently held with Health Canada outlining the evidence of effectiveness of Sativex in this patient population. Following this meeting, Health Canada advised that, on the basis of the clinical data presented, a submission for consideration under the Notice of Compliance with Conditions policy be made.

GW has completed a Phase III study in Europe in 177 patients with cancer pain. The trial was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication. In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial. In this study, Sativex achieved a statistically significant improvement in comparison with placebo in pain as measured on a numerical rating scale, a primary endpoint of the study. A responder analysis showed that 43 percent of patients on Sativex showed a greater than 30 percent improvement in their pain.

Sativex is a buccal spray composed primarily of tetrahydrocannabinol and cannabidiol, a non-psychoactive cannabinoid. The product is standardized by both composition and dose. Sativex is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cells. These receptors are distributed throughout the pain pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.