First FDA-Approved Cannabis Drug Available in US Prescription

The first cannabis product approved by the FDA is now available on prescription in all 50 states. Epidiolex is an oral solution taken twice daily to treat two types of epileptic syndromes developed by GW Pharmaceuticals. The drug can be prescribed by general practitioners to patients with either Dravet's syndrome, a rare brain genetic dysfunction occurring in the first year of life, or Lennox-Gastaut syndrome, a form of epilepsy at the time of treatment. Origin of several types of convulsions.

The syndrome is usually diagnosed from very early childhood, between 3 and 5 years. "We are excited to announce that EPIDIOLEX is now available on a doctor's prescription as a new treatment option for LGS and Dravet patients, two of the most difficult to manage. treat the forms of childhood epilepsy, "said Justin Gover, chief executive officer of GW Pharmaceuticals, in a written statement from the company.

The drug could improve the quality of life of patients with epilepsy

"Because these patients have still not responded well to the drugs available to treat their seizures, new treatments are needed to reduce the frequency and impact of seizures. We are committed to ensuring that these patients can access this new cannabinoid-based drug that has been the subject of extensive studies during clinical trials, which was manufactured to ensure the quality and uniformity and who can benefit from the insurance of appropriate patients. "

Epidiolex has removed all the barriers required to obtain full FDA approval. It started being recommended by an approval committee in April before being listed as a Schedule V substance and fully approved in September. "Adequate and well-controlled clinical studies supported the approval of Epidiolex. Prescribers can therefore be confident in the uniform strength of the drug and its consistent administration that support the appropriate dosage required to treat patients with these complex and severe epileptic syndromes, "said FDA Commissioner Scott Gottlieb. MD.

DEA will work with researchers on cannabis drugs

Marijuana-derived marijuana and CBD remain illegal in the United States unless they are contained in FDA-approved products such as Epidiolex. Scientists are pushing for more research on the medical benefits of marijuana, the Department for Drug Control (DEA) says it will work with scientists to help them in their research.

"The DEA will continue to support scientific and scientific research that promotes the legitimate therapeutic uses of FDA-approved cannabis components, in accordance with federal law," said Uttam Dhillon, acting administrator of the DEA in a written statement. "The DEA is committed to continuing to work with our federal partners to find ways to make the research process more efficient and cost-effective."

The pharmaceutical company says insurance should pay

GW Pharmaceuticals indicates that Epidiolex will be available for approximately $ 32,500 one year. They claim that this price is consistent with other FDA-approved antiepileptic drugs and expects insurance to cover the majority of costs for patients. They are also launching a Patient Support Program "to help patients who have been prescribed Epidiolex to access treatment." This program offers patient / caregiver-focused education and resources to reduce direct costs or provide the product. free." eligible patients. "

Side effects of Epidiolex include drowsiness, decreased appetite, diarrhea and increased liver enzymes. Some patients may also have suicidal thoughts. The Epidiolex website urges patients to use the medication exactly as directed and to seek immediate medical attention if other side effects or depressive thoughts are present.