Nasal spray to be approved in Europe.
A cannabis-based nasal spray will receive approval later this month for marketing in the United Kingdom and Spain as a medicine for multiple sclerosis, makers of the compound announced this week.
GW Pharmaceuticals, makers of Sativex, won earlier regulatory approval for the use of Sativex in Canada in 2005. Users spray the cannabis mist under their tongues for the relief of spasticity due to M.S. It is intended primarily as an “add-on treatment for symptom improvement,” according to The Pharma Letter, in patients “who have not responded adequately to other anti-spasticity medication.”
The London Evening Standard reported that the company, which grows its marijuana in undisclosed locations in England, expects the treatment to be offered as early as June under marketing agreements with Bayer of Germany and Almirall of Spain. A Japanese pharmaceutical firm has marketing rights to Sativex in the U.S., but the drug has not garnered any significant attention or approval here. The Evening Standard reported that marketing rights from Bayer and Almirall could add up to more than $20 million when the medicine is formally approved.
European regulatory officials stress that they still have to finalize local wording on product packaging and associated documents before final marketing approval can be granted.
GW Pharmaceuticals has been working on Sativex for more than a decade now, as a medication for multiple sclerosis patients, as well as patients suffering from advanced cancers. Chairman Geoffrey Guy said that the company was “transitioning from a late-stage development company to a commercial pharmaceutical business with excellent growth prospects.”
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