GW Pharma Could Win FDA Approval in Early 2016

GW Pharma appears poised to enter the United States cannabis market.

The British company reportedly could get clearance from the U.S. Food and Drug Administration for a CBD-based product by early next year.

The drug, called Epidiolex, previously received fast-track status from the FDA and is now in the final Phase 3 study for pediatric epilepsy disorders, according to the Huffington Post. Results are expected in the first quarter of next year.

Epidiolex is expected to “breeze through this final stage,” and it could be on the market in the first half of 2016, the site reported.

The drug contains cannabidiol oil extracted from marijuana and is used primarily to treat epilepsy.

Since Epidiolex is derived from marijuana, GW Pharmaceuticals will likely have to invest in infrastructure to grow cannabis in the United States rather than ship the product over from the U.K. It would then have to manufacture the drug in whichever states it wants to sell Epidiolex in.

One comment on “GW Pharma Could Win FDA Approval in Early 2016
  1. Alan Brochstein on

    This links to an article that is factually incorrect. Epidiolex won’t be on the market in early 2016. Most likely, if approved, it would be 2017. The data from the Phase 3 trial will be released in Q1-2016. This would precede a filing with the FDA and then a review. There would also be some time between approval, if they receive it, and the launch.

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