Authored by Emma Court via MarketWatch


GWPH-300x164 GW Pharma shares surge on FDA briefing document that hints at approval of cannabis-derived drug


GW Pharmaceuticals PLC  shares surged 10.3% in heavy Tuesday morning trade after the release of positive briefing documents for a Food and Drug Administration advisory committee meeting regarding the company’s cannabis-derived drug epidiolex.

Epidiolex — which contains cannabidiol (CBD), rather than the psychoactive component of cannabis, THC — is intended for seizures associated with two rare types of childhood epilepsy.

The drug’s cannabis-derived nature has been expected to be a sticking point in the approval process, and if approved, it would be the country’s first cannabis-derived drug. But the FDA briefing documents raised no issues with the drug containing CBD, citing the FDA’s controlled substances staff’s conclusion that CBD “has a negligible abuse potential.”

The briefing document also found that safety risks connected to CBD seemed acceptable, including risk of liver injury, which can be managed and monitored. “Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with [Lennox-Gastaut syndrome] and [Dravet syndrome],” the briefing document said.

The FDA’s advisory committee will consider the drug on Thursday. The FDA commonly follows an advisory committee’s recommendation, but there are exceptions. GW Pharma shares have lifted 18% month-to-date, compared with a 2.5% rise in the S&P 500.


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