First FDA-Approved Cannabis Drug Available For Prescription in U.S

The first FDA approved cannabis product is now available via prescription in all 50 states. Epidiolex is a twice-daily oral solution is used to treat two types of epileptic syndromes developed by GW Pharmaceuticals. The drug can be prescribed by general practitioners to patients who suffer from either Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, or Lennox-Gastaut syndrome, a form of epilepsy that causes multiple types of seizures.

The syndrome is usually diagnosed in very early childhood between the ages of 3 and 5. “We are delighted to announce that EPIDIOLEX is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals in a written statement from the company.

The drug could raise the quality of life for the epilepsy patients

“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures. We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”

Epidiolex cleared all the required hurdles for full FDA approval, beginning by being recommended by an approval committee in April before being classified as a Schedule V substance, and being fully approved in September. “Adequate and well-controlled clinical studies supported Epidiolex approval, so prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes,” said FDA Commissioner Scott Gottlieb, M.D.

DEA will work with researchers on cannabis containing meds

Marijuana and CBD derived from marijuana remain illegal in the United States unless they are in products approved by the FDA such as Epidiolex. Scientists are pushing for more research into the medical benefits of marijuana, the Department for Drug Enforcement (DEA) says it will work with the scientists to assist in their research.

“DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” said Acting DEA Administrator Uttam Dhillon in a written statement. “DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.”

The drug company says insurance should pay

GW Pharmaceuticals says Epidiolex will be available for around $32,500 a year. They assert this price is in line 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 gain access to therapy. The program offers patient/caregiver-focused education and resources to help lower out-of-pocket costs or provide the product at no cost for eligible patients."

The side effects of Epidiolex include sleepiness, decreased appetite, diarrhea and an increase in liver enzymes. Some patients may also experience suicidal thoughts. The Epidiolex website urges patients to use the drug exactly as directed and to seek medical advice immediately if other side effects or depressive thoughts present.