Health

The First Ever Cannabis-Based Prescription Drug Approved by FDA

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Epidiolex is the first cannabis-based medication that got approval by the US Food and Drug Administration and is available now as a prescription drug in all the 50 states. The oral medication recommended in the dosage of twice a day is approved for patients above two years of age for the treatment of two types of syndromes associated with epilepsy. Epidolex can treat Dravet syndrome which is a rare brain disorder starting in the first year as well as Lennox-Gastaut syndrome which is a type of epilepsy with different kinds of seizures beginning in early childhood between the age 3 and 5. 

One of the most effective CBD Pills ever developed, Epidolex is introduced as a new therapy to reduce the impact of seizures in patients who did not respond properly to seizure medications in the past. According to a statement by Justin Gover, CEO of GW Pharmaceuticals that makes Epidiolex, the company strives to make sure a large number of patients can access the cannabis-based medication developed after studies performed in clinics and made to meet consistency and quality standards. It is also eligible for coverage by insurance for the right patients. 

In April 2018, Epidiolex was recommended for FDA approval by an advisory committee and it got the approval in June. It was in September 2018 that the Drug Enforcement Administration categorized the CBD Pills as a Schedule V Substance thereby paving the way for its legal prescription by doctors throughout the United States. Doctors can confidently prescribe the medicine as adequate clinical studies support its approval. The drug features the right strength and consistent delivery supporting appropriate dosage required for treating the patients with complications associated with the epilepsy syndromes. 

During the clinical trials, when Epidiolex was added to other seizure medicines, the seizures were reduced by about 28 percent as compared to a placebo. The tests proved it to be clearly effective. Some people saw amazing improvements while others had modest improvements and some did not see any. It is not a miracle drug but is an effective drug with minimal side effects as compared to other seizure prescriptions. Some of the common side effects of Epidiolex include reduced appetite, sleepiness, diarrhea, increased liver enzymes, etc. The effectiveness of this drug falls somewhere between ‘fair’ and ‘very good’. The FDA approval of this CBD-based drug signals the validation of the science of cannabis medication.

According to GW Pharmaceuticals, the average list price of the drug is $32500 per year. It is expected to be covered by most insurance plans and the price is in line with similar drugs prescribed for epilepsy. A patient support program is also introduced to help the patients taking Epidiolex to get access to therapy. This program provides education and resources for patients and their caregivers to get the medicine at pocket-friendly costs or at no cost. Though Epidiolex is approved only for the treatment of two seizure disorders, doctors can even prescribe it ‘off label’ for other conditions. Many patients would want to try it and many doctors would try to prescribe it for those who might benefit from it. According to Matthew Johnson, magic mushrooms Canada also has potential to treat other substance use disorders, including alcohol and cocaine addiction.