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Setback for Sativex

Mark Miller

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Last week, UK-based GW Pharmaceuticals acknowledged that its cannabis-based oral spray, Sativex, failed a late-stage clinical trial as the experimental drug showed no evidence of reducing pain in cancer patients.

Participants in the initial Phase 3 trial were given Sativex, which is sprayed in the mouth, or a placebo three to 10 times a day for five weeks. However, test subjects receiving Sativex reported a statistically insignificant difference in pain relief from those receiving the placebo.

The disappointing trial results initially plunged GW stock around 13 percent on the morning of January 8, the first poor showing from the company since it listed on Nasdaq in 2013. But thanks to an encouraging update on GW’s cannabis-based childhood epilepsy drug Epidiolex, the company’s stock actually rebounded and closed up two percent.

The Phase 3 results are viewed by some as a blow against cannabis-based pharmaceutical products, as opposed to the entire plant in its pure, natural and medically effective form.

GW is scheduled to conduct further Phase 3 trials later this year and the company is hopeful that Sativex will eventually be approved for pain treatment in cancer patients. “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,” GW chief executive Justin Gover said.

Sativex is currently approved for treating symptoms of multiple sclerosis.

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