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news.GW Pharmaceuticals has filed a regulatory submission for its drug Sativex, which will be used for the treatment of spasticity due to multiple sclerosis (MS). This submission follows the successful results in a Phase III trial of Sativex, where the drug reduced spasticity in multiple sclerosis patients.
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The regulatory submission has been filed in the UK and Spain under the European decentralised procedure. The UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as Reference Member State and has validated the application.
If it is approved, Sativex will be marketed in the UK by Bayer HealthCare and in the rest of Europe, by Almirall.
Following the approval in the UK and Spain, submissions for approval will be made in additional European countries during 2010 under the mutual recognition procedure, said the company.
Dr Stephen Wright, GW’s R&D Director, said: “We are pleased to have completed and filed the regulatory submission within a very short period of time of receiving the latest positive Phase III data. We look forward to working with the regulatory authorities in their review of the application.”