FDA Approved First Cannabis-Based Drug Epidiolex for Epilepsy
The U.S. Food and Drug Administration (FDA) approved new cannabis-based drug Epidiolex on June 25, 2018, which is indicated for treatment of epilepsy
Epidiolex is an oral drug developed by GW Research Ltd., which is indicated for the treatment of rare to severe forms of epilepsy—Lennox-Gastaut syndrome and Dravet syndrome—in patients over the age of two.
New approved drug is syrup-like medicine, which contains cannabidiol (CBD) as an active ingredient. However, CBD is considered as a Schedule I substance in the United States under the Controlled Substances Act, as it is derived from the marijuana plant. Therefore, patients will not be able to access Epidiolex until CBD is rescheduled by the DEA, which is expected to take place within 90 days, according to GW Research Ltd. Epidiolex is the first cannabis-based drug to be legalized in the United States.
Previous studies reported that CBD can efficiently treat medical conditions such as autism, anxiety, depression, and cancer.
Recent data suggests that it can potentially treat seizures, including Dravet syndrome and Lennox-Gastaut syndrome. As a part of the study, 516 patients were involved in the drug efficacy test of Epidiolex and three clinical trials were conducted for the same.
It was observed that in combination with other medications, Epidiolex reduced the frequency of seizures as compared to placebos.
According to the Medical Cannabis Market report published by Coherent Market Insights, Increasing approval of medicinal cannabis products and growing research and development activities in the medical cannabis market are expected to support the development of novel drugs for treatment of various disorders.
According to the FDA, Epidiolex must be administered with a patient Medication Guide that describes the drug’s various uses and risks, as it exhibits some side effects such as sleepiness, lethargy, decreased appetite, diarrhea, rashes, sleep problems, and other health issues.
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