Closely monitored the drug is made from the marijuana plant reduces seizures in children with severe forms of epilepsy and guarantees approval in the United States, said on Tuesday.
British drug company GW pharmaceuticals is seeking permission to sell its purified form of compound found in marijuana — does not get users high quality medicines for rare, hard-to-treat seizures in children. In case of success, the liquid formulation of the company will be the first government-approved drug derived from cannabis plants in the United States
The approval of food and drug administration will technically limit the treatment to a small group of epilepsy patients. But doctors are able to prescribe it for other purposes and it can stimulate new pharmaceutical research and interest in other cannabis products. Man-made version another ingredient in marijuana had previously been approved for other purposes.
The FDA published its opinion on the experimental drug Epidiolex ahead of a public meeting on Thursday, when the panel of outside experts will vote on the safety and efficacy of the drug. This is an optional recommendation that FDA will consider in its final decision until the end of June.
Patients receiving the treatment had fewer seizures, in accordance with the internal review, the FDA posted online. Scientists came to the conclusion that the filing of GW Pharmaceuticals “appears to support the claim” despite some potential side effects including risk of liver damage.
More than two dozen States allow the use of marijuana for various diseases, but the FDA has not approved it for any medical use. In 2016, the Agency recommended against easing Federal restrictions on marijuana. The United States continues klassificeret marijuana as a high-risk substance with no medical use, along with other illicit drugs like heroin and LSD.
For many years, and desperate patients and parents insisted on greater access to medical marijuana products for a range of diseases, including pain, PTSD and epilepsy, and only anecdotal stories and limited research on their side.
But research conducted by GW pharmaceuticals have begun to change this picture.
In three studies involving over 500 patients, Epidiolex, in General, to reduce the number of monthly attacks by about 40 percent, compared with reductions between 15 and 20% for patients who received a dummy medicine.
The majority of patients in the study already taking at least three other medications to try to control his seizures.
Epidiolex is essentially pharmaceutical grade version of cannabidiol, or CBD oil, which some parents use for many years to treat children with epilepsy. CBD is one of over 100 chemicals contained in the plant cannabis sativa and contains no THC, the ingredient that gives marijuana its psychoactive effect.
Currently, CBD oil sold online and in specialty stores throughout the United States, although its legal status remains murky. Most manufacturers say that their oil is made from hemp, and the plant family cannabis, which contains little THC and can be grown legally in some States for clothes, food and other applications.
GW pharmaceuticals declined to comment on the price of the drug in anticipation of the decision. Analysts on wall Street estimated it could cost more than $25,000 per year, with the annual sales volume reaches $ 1 billion.
A doctor who treats children with epilepsy said that it is important to have the FDA approved version to the CBD.
“I think it needs to be approved because everyone is using it online, not knowing … and no one looks at interaction with other medications,” said Dr. Joan Conry children’s national health system in Washington, which was not involved in the research.
Conry and other researchers say it’s still not clear why the CBD reduces seizures in some patients.
GW pharmaceuticals makes its preparation from plants of hemp which are specially bred to contain high levels of CBD. He’s looking for approval for two rare forms of pediatric epilepsy — dravet and Lennox gasto syndrome.
Common side effects included diarrhea, vomiting, fatigue, and sleep problems. Management of the commentators drew attention to the more serious problems with potential damage to the liver, but said that doctors can manage the risk by controlling the level of enzymes patients.
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Matthew Perrone can be followed on Twitter: AP—FDAwriter @
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Sourse: abcnews.go.com
