Saturday January 20th 2018

Few more hurdles and MS patients in France will have Sativex

sativexThe French government announced the approval of limited use of Sativex, a mouth spray based on the THC that is found in cannabis, for those who suffer from multiple sclerosis (MS).

Sativex was developed and manufactured by the British company GW Pharmaceuticals, to be used for those who suffer from spasticity and, although it is already approved in 17 European countries for it, it is still in drug trails in other countries like Australia, New Zealand, Kuwait and the United States.

A company the name of Otsuka Pharmaceutical Co Ltd. holds the U.S. license. They have exclusive rights to it here in the States for it to be used for cancer pain and the director of GW’s R&D, Dr. Steven Wright 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.”

Otsuka and GW expect there will be a couple more Phase III trials before submitting a New Drug Application to the FDA for cancer and have, since last year, opened Phase III trial for spasticity in those who suffer from MS for efficacy and safety and expect there to be a rather large “target indication for the product in the U.S.

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France hasn’t been ready to jump on the bandwagon for medical cannabis in recent years, just like the United States it was like pulling teeth, but they have finally made that first step.

They still have some regulatory impediments to mire through, things like sitting down with the French National Agency of Medicine and Health Products Safety (ANSM) to work out national pricing and reimbursement procedures, but once that is completed, French patients should be able to receive the prescription only medication.

The United State’s FDA is different in that the FDA is only suppose to look at safety and efficacy, not “national pricing” nor “reimbursement procedures” as to whether a medication is approved for use.

Their press release, offered up by GW Pharmaceuticals Chief Executive Officer Justin Grover stated: “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. We look forward to working with our partners, Almirall, towards the launch of Sativex in this important European country.”

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