Sativex is on the way to becoming the first cannabis-based drug marketed in France, if the Haute Autorité de santé validates its marketing. While the State of New York announced the authorization of the consumption of medical marijuana on Wednesday, January 8, the Ministry of Health declared that: “The National Agency for Medicines and Health Products Safety (ANSM) has just granted SATIVEX, by decision of January 8, 2014, a marketing authorization.”
The indication of this oral spray will be extremely limited and it will be prescribed only to patients with multiple sclerosis to relieve severe contractures (spasticity), resistant to other treatments, says the ministry. The initial prescription, lasting six months, will be reserved for neurologists and hospital rehabilitation physicians. General practitioners will be allowed to renew the prescription between two hospital visits because narcotic drugs cannot be dispensed for more than 28 days.
No marketing before 2015
Christophe Vandeputte, the boss of the French branch of the Almirall laboratory, which distributes this product in other countries, welcomes this “good news for French patients who were almost the last in Europe not to be able to benefit from Sativex”, he says, quoted by The world. “This marketing authorization represents the culmination of three years of discussions. It was a delicate matter in an explosive environment, but the outcome is very positive,” he adds.
ANSM examined the clinical studies and the effectiveness of the drug before determining the conditions of prescriptions and delivery, indicates the daily. The next step which awaits the Sativex is the evaluation by the High Authority of Health, its possible marketing will not therefore be effective before 2015. Distributed by pharmacies, it will have to be kept in coffers like the drugs containing opiates.
