GW Pharmaceuticals gets FDA OK to skip to phase 3 trial of cannabis pain drug

By Angela McDaniels

Seattle, Jan. 4 - GW Pharmaceuticals said it has been given permission by the Food and Drug Administration to begin clinical trials for Sativex in the United States at the phase 3 stage. The drug is already approved in Canada, and the FDA gave the go-ahead after reviewing quality, safety and efficacy data generated by the company on Sativex in Europe.

The company received permission after submitting an Investigational New Drug Application for Sativex, a cannabis-based, oral-mucosal spray composed primarily of tetrahydrocannabinol and cannabidiol, a non-psychoactive cannabinoid, for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.

"A previous phase 3 clinical study showed that Sativex achieved a statistically significant improvement in pain relief in terminally ill cancer patients," researcher Russell K. Portenoy of Beth Israel Medical Center in New York said in a company news release.

"Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex will be critical in defining their role."

The 250-patient, double-blind, randomized, placebo-controlled phase 3 study will evaluate the effect of Sativex in relieving average daily pain, reducing the use of breakthrough opioid medications, improving the quality of sleep and relevant aspects of quality of life, the company said.

The company said it expects to begin the U.S. clinical program in late 2006 and that U.S. regulatory submission will likely occur 24 to 36 months thereafter. Sativex is approved in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis.

More than 250,000 terminal cancer patients in the United States take opioids for pain relief, the company said.

GW is based in London and develops cannabis-derived pharmaceutical products for patients with multiple sclerosis, spinal cord injury, rheumatoid arthritis, neuropathic pain, cancer pain and other severe medical conditions.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.