Thursday, January 05, 2006

Sativex Marijuana Mist Approved for Clinical Trials in The U.S.

GW Pharmaceutical announced that the FDA has approved its Investigational New Drug (IND) application for Sativex to treat cancer pain that hasn’t been relieved by other medications. Sativex is an oral spray composed primarily of THC and CBD, the active compound and a non-psychoactive compound found in marijuana.

After reviewing the European data on the safety and quality of Sativex, the FDA has agreed to allow Sativex to proceed to Phase III clinical trials in the U.S., which will involve 250 patients in a controlled study to evaluate the effects of Sativex on cancer pain.

One of the positive aspects of Sativex is that it allows patients with severe pain to reduce their dependency on opioid drugs, which often do not provide sufficient relief and can affect a person's ability to function on a daily basis. Phase III trials are expected to begin sometime late this year, and within 2-3 years the company can be expected to file a regulatory submission, officially making Sativex available in the US.

For more information on Sativex and U.S. clinical trials visit:


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