GW Pharmaceuticals to launch new oromucosal spray in Austria
GW Pharmaceuticals has received regulatory approval in Austria for Sativex (Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as a treatment of spasticity due to multiple sclerosis (MS).
The company plans to launch the product in Austria after completion of the national pricing and reimbursement process.
Almirall, GW's marketing partner, will market Sativex in Austria.
In November 2011 the company filed a new regulatory application, under the European Mutual Recognition Procedure (MRP), to expand Sativex approvals to additional European countries.
The dossier has been validated and is now under technical review by regulatory authorities in Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia, the company said.
The company is expecting that this new MRP process should complete around mid 2012.
Sativex is also in Phase III clinical development as a treatment for cancer pain.
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