GW Cannabinoid Drug Fails Cancer Pain Trial

There was little difference in the adverse event pattern between Sativex and a placebo. There were 38, or 19%, withdrawals due to adverse events on Sativex, compared to 29, or 15%, on the placebo. Unfortunately, the results were such that Sativex did not meet the primary endpoint in the first trial by not demonstrating a statistically significant difference from the placebo.

The main adverse events reported for the Sativex trial were:

• Neoplasm progression at 16% on Sativex, compared to 18% on the placebo
• Somnolence at 12% on Sativex, versus 4% on the placebo
• Dizziness at 8% on Sativex, against 5% on the placebo

Justin Gover, GW’s CEO, explained the current situation and then the outlook for later this year:

Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population. We have two additional pivotal Phase 3 trials ongoing which, if positive, would still allow us to submit a New Drug Application with the US FDA. We look forward to results from these two further studies later this year.

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GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. GW has a deep pipeline of additional cannabinoid product candidates, which includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type 2 diabetes and schizophrenia.

Shares of GW closed Wednesday up 2% at $71.06. In premarket trading on Thursday, shares were down 8% at $65.39. The stock has, or had, a consensus analyst price target of $119.25, as well as a 52-week trading range of $40.00 to $111.46.