French Ministry of Health approved a drug containing marijuana extract
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Last Update: 2014-01-13
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Source: Internet
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Author: User
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According to France's "Le Figaro" website reported on January 9th, after the approval of the French Ministry of health, oral mucosal spray Sativex has been listed in the French market Sativex is the world's first prescription drug for marijuana, which can be used in some cases to relieve the symptoms of stiffness caused by multiple sclerosis Sativex is used to treat some symptoms caused by multiple sclerosis Many patients with the disease hope that the new drug will come to France as soon as possible Is it a promise and guarantee from the Ministry of health that the drug is approved for marketing? In any case, the Ministry of health soon announced on Thursday (9) the decision made by the French National Agency for medicine and health product safety (ansm) the day before: to issue an AMM listing license to the drug sativex and approve its listing Sativex is a drug containing marijuana extract, which is used in the form of spray It is reported that the decision should be formally implemented in France in a few months It is very important that the drug is made from a part of marijuana and not the whole product is marijuana, because it means that patients can get muscle therapy, achieve certain effect and avoid the psychological effect of a "marijuana consumer" As a result, there is little risk of misuse of the drug However, in order to make the drug containing prohibited substances enter the market successfully after the evaluation of the State Administration of medicine and health product safety and the high authority of health, French health minister Marisol duhanna had intended to commit to change French legislation Finally, the government issued a decree to adopt the practice, which was published in the official newspaper on June 7, 2013 Olivier heinzlef, a neurologist and President of the French Association for the treatment of multiple sclerosis, responded: "we are very satisfied and happy with the commitment of the Minister of health, because it can bring new treatments to patients." "It's a small step forward, but not a revolution." in fact, the decision made by the AMM drug marketing licensing committee is not surprising The British laboratory of Spanish company almirall recommended that sativex be marketed in France, because the drug will be marketed in more than 20 countries from now on Professor Patrick vermersch, head of the Department of multiple sclerosis, explained: "we heard from our foreign colleagues at international conferences a long time ago about the good effects of this drug." Some of these patients have been included in the clinical study of sativex "It's a small step forward, but not a revolution," Professor Patrick vermersch told the Figaro newspaper In addition, the European drug administration also made comments After an exchange of views on the effectiveness criteria derived from laboratory studies, the European drug administration, after evaluating the data provided by the laboratory, produced a risk-benefit report, which proved that the advantages of the drug were greater than the disadvantages Since the marijuana extract in the drug targets the main symptoms of multiple sclerosis, muscle stiffness (muscle spasm) is difficult to quantify When the drug is considered to be effective, the laboratory will determine a threshold based on a questionnaire In fact, the research shows that if the treatment does not reach the threshold in the first four weeks, then it may not; if the opposite, the treatment may exceed the threshold, and the efficacy may not be guaranteed, but at least it is certain that almost all potential long-term allergic diseases will be exposed Professor vermersch said: "in about half of the patients, sativex is ineffective, but the most commonly used treatment is the same, such as baclofen tablets Therefore, it is necessary to develop a new drug " Dr heinzlef added: "the emergence of new drugs is crucial, not to mention that current drugs are not always well tolerated, especially because of sedative effects." It should be noted that the first prescription of sativex should be jointly formulated by a neurologist and a hospital rehabilitation therapist.
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