GW Pharmaceuticals is taking its chance at the FDA. The company is working on a new application for approval of Sativex, the cannabinoid drug now sold in Canada and Europe to treat spasticity in multiple sclerosis patients.
Sativex isn't a big seller, at least not yet. But as a cannabinoid--derived from marijuana--the drug, and its potential FDA approval, has made plenty of headlines.
Meanwhile, European marketing partner Almirall is still rolling the drug out country by country. Its plans for Germany hit a snag earlier this year when cost authorities set a price much lower than other European countries did. Italy took the drug on last quarter, with reimbursement levels comparable to Spain's €440 euros ($583) per three-vial pack; during the same period, Almirall put Sativex on the private market in Poland, Austria and Sweden. It's also sold in the U.K., Canada and Denmark, among others.
And now, with U.S. partner Otsuka Pharmaceutical, GW is working with the FDA on a new Phase III program testing Sativex as an MS spasticity treatment. The company is already working with Otsuka in Sativex trials for cancer pain. Results from the latter studies are due next year.
Cancer pain is still the first indication on GW's list for the FDA, the company said. So, the new MS spasticity trial "is an important extension of GW's and Otsuka's ambitions for Sativex in the U.S.," CEO Justin Gover said in a statement.
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Editor's note: This story was updated to clarify Sativex's status at FDA and correct the reimbursement rate in Spain, which is €440 per pack, rather than €4.40.