Europe issues a favorable recommendation for the approval in France of Sativex. This cannabis-based pain reliever, prescribed for multiple sclerosis, should arrive in pharmacies in 2015.
The British laboratory GW Pharmaceuticals announced on Monday in a press release that it had obtained, at the European level, a favorable recommendation for the approval in France of Sativex, a treatment of spasticity in patients with multiple sclerosis (MS) at cannabinoid base. “The next step in the regulatory process is to work with the Medicines Safety Agency (ANSM) to finalize all country specific requirements. France should grant an MA to the product once this step is completed, ”comments the laboratory.
“The European procedure is completed but all the French part remains to be done”, confides a spokesperson for the agency, contacted by the Medical Press Agency. “The AMM will not be notified in France before mid-November,” she added. Finally, according to the French subsidiary of the laboratory which will market the product, we continue to hope to obtain the MA in the first quarter of 2014, for a launch one year later. Back to this cannabis-based painkiller, whose arrival in France is dividing the medical community.
Medicinal cannabis divides French doctors
However, therapeutic cannabis remains a very heated debate in France today. On the one hand and for detractors of therapeutic cannabis, the discussion immediately slips onto a social issue and moves away from the medical field. “It is a disguised means to achieve its decriminalization”, recently confided to the daily La Croix Jean Costentin. For this professor of pharmacology from the University Hospital of Rouen, “the benefit of these drugs remains extremely modest while the risks are numerous. Other drugs exist to treat pain, ”he added.
On the other hand, for supporters of therapeutic cannabis, one should not be afraid of the arrival of the product in pharmacies. “ TOotoday, we do not deprive a patient of morphine on the pretext that there is a risk of misuse, argued Professor François Chast, head of the clinical pharmacy department of the Paris Center university hospitals. Morphine has acquired a new status because we know that it is a very effective drug in severe pain. There is a growing conviction that the Sativex spray is an interesting therapeutic element in certain pains related to muscle spasticity. So, let the ANSM experts speak. We don’t have to worry at all “, concluded François Chast. And today, it is indeed up to the Medicines Agency to settle the debate.
ANSM is currently examining MA applications
Since a decree published in the Official Journal in June, Ansm has started examining marketing authorization applications for drugs whose active ingredients are cannabinoids. The text had, in reality, for primary objective to allow the director of the Ansm to authorize the sale of Sativex.
Entered into force in June, the decree in question modifies the regulatory part of the Public Health Code concerning “other poisonous substances and preparations” and in particular article R51032-86 relating specifically to cannabis. From now on, it is registered that the operations of manufacture, transport, import, export, offer, transfer, acquisition or use relating to these drugs “are no longer prohibited”, in accordance with a European directive.
Sativex is already authorized in the United States, Canada and certain European countries (Switzerland, England).
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