GW Pharmaceuticals PLC (NASDAQ: GWPH) and Otsuka Pharmaceutical Development & Commercialization reported top-line results from the first of three Phase 3 trials for Sativex. The drug candidate is an investigational product for the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. With so much attention around drugs tied to medical marijuana and its derivatives, this could be a big deal for investors in this field.

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.

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