France Approves Multiple Sclerosis Treatment Based On Cannabis

France 24 reports that the French government’s health ministry has announced its approval for limited use of Sativex, a cannabinoid mouth spray, for treatment of patients suffering from multiple sclerosis (MS). Sativex, developed and manufactured by the British company GW Pharmaceuticals, will be the first marijuana-based medicine to be made available in the country.

France 24 also notes that the drug still has a few more regulatory hurdles to negotiate before it is for sale by prescription. GW Pharmaceuticals says the next step in the regulatory process is to work with the French National Agency of Medicine and Health Products Safety (ANSM) to finalize any country-specific requirements. Following completion of this next step, it is then expected that France will issue a national marketing authorization. Launch timing in France is dependent on completion of subsequent national pricing and reimbursement procedures. Sativex will be commercialized in France by GW’s European partner, Almirall S.A., an international pharmaceutical company headquartered in Barcelona, Spain, that researches, develops, manufactures and commercializes its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.

In October, 2013, GW Pharmaceuticals had announced the successful closing of the European Mutual Recognition Procedure (MRP) in France for Sativex oromucosal spray in the treatment of spasticity due to MS and a resulting recommendation for approval by the French authorities.

“The successful completion of this regulatory process for Sativex in France maintains our positive regulatory track record for Sativex, which is already approved in 22 countries, and provides further endorsement of the important role Sativex can play in meeting a substantial unmet need of people with Multiple Sclerosis,” says GW Pharmaceuticals Chief Executive Officer Justin Gover in a GW release. “We look forward to working with our partners, Almirall, towards the launch of Sativex in this important European country.”

Sativex is approved as a treatment for MS spasticity in 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further 8 European countries, as well as Australia, New Zealand and Kuwait. The US license to Sativex is held by Otsuka Pharmaceutical Co. Ltd. in the United States and to Bayer HealthCare AG in the UK and Canada. GW Pharmaceuticals has signed a deal to have Novartis (makers of Gilenya) market Sativex in parts of Asia, the Middle East, Australia, New Zealand and Africa, so is moving ahead in those markets. .

In 2007 GW and Otsuka Phamaceutical entered into an exclusive agreement for Otsuka to develop and market Sativex in the United States. They received permission from the US regulatory authority and the FDA to directly enter late stage trials in the US. Results were released in March. The randomized, double-blind, placebo controlled study was concluded very encouragingly. Dr. Steven Wright, GW’s R&D director said, “We are very pleased to have successfully completed phase II of studies supporting the efficacy of Sativex in Cancer pain, we are now working closely with Otsuka in preparing to develop phase III development of Sativex in the United States.” The current US development program anticipates two more Phase III trials prior to a subsequent submission of a New Drug Application to the FDA.

In the United States, GW announced in August 2013 that it had opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex for the treatment of MS spasticity. GW expects the U.S. Phase 3 trial to commence in 2014. Sativex is also currently in Phase 3 clinical trials as a treatment for cancer pain. This represents the lead target indication for the product in the US.

Marijuana’s role as a medication is complex and controversial. It was used as a medication in the nineteenth and early twentieth centuries but was outlawed in most western countries in mid twentieth century. In Canada, the federal government has developed a medicinal marijuana program, which allows people who meet certain criteria to possess and use marijuana therapeutically. MS is among the conditions for which a permit can be applied. In some cases, Health Canada authorized medical marijuana grow-ops to provide marijuana to people who hold medical use permits.

Health Canada approval of Sativex on April 19, 2005, made Canada the first county in the world in which the cannabis-based spray is available as a prescribed treatment for MS-related pain. Health Canada approved Sativex with conditions, under its Notice of Compliance with Conditions (NOC/c) policy. This authorization reflects the promising nature of the clinical evidence which must be confirmed with further studies. Products approved under Health Canada’s NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use.

In August 2007, GW also announced the approval (NOC/c) in Canada of Sativex as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.