According to the National Medicines Safety Agency (ANSM), Sativex, a pain reliever in the form of an oral spray, could obtain its marketing authorization in France by the end of 2013. Its marketing authorization market (AMM) had been requested in July by the Almirall laboratory which will distribute this drug in France.
Sativex is already available in 22 countries including 17 European countries (Austria, Germany, Belgium, Denmark, Spain, Finland, Ireland, Iceland, Italy, Luxembourg, Norway, Netherlands, Poland, Portugal, Czech Republic, Slovakia and Sweden) . The Almirall laboratory “hopes to be able to market it at best in 2015”, its CEO Christophe Vandeputte told AFP on Monday.
“Until now, the Public Health Code prohibited the use of cannabis derivatives for therapeutic purposes in France, but a decree published in the Official Journal on June 7, 2013 and entered into force on June 8 had paved the way for the sale of drugs containing cannabis ”recalls AFP.
The National Agency for the Safety of Medicines and Health Products can since “grant marketing authorization to pharmaceutical specialties based on cannabis or its derivatives and authorize operations of manufacture, transport, import, ‘export, holding, offer, transfer, acquisition or use relating to these specialties ”.
The pharmaceutical benefit of cannabis
Therapeutic cannabis has many virtues: painkiller, antispasmodic, anti-vomiting, it helps fight nausea and loss of appetite. It is already used in many countries (United States, Finland, Germany, Belgium, etc.) for patients with multiple sclerosis, HIV, or undergoing chemotherapy treatment.
In France, only Marinol, a low-dose synthetic cannabis-based drug prescribed to patients with AIDS who have lost their appetite, has a temporary authorization for use (ATU).
