FDA Approval for Cannabis Based Epidiolex Medicine Against Seizures

June 27, 2018  Source: FiercePharma 161

Since the FDA approved the GW Pharma anti-seizure drug named Epidiolex derived from cannabis, other pharma companies now also have a roadmap on how to develop marijuana-based drugs.

Epidiolex, also known as purified cannabidiol was approved to treat Lennox-Gastaut syndrome and Dravet syndrome specifically in patients aged 2 and older. Both these conditions start during childhood. Recurrent seizures pose a huge risk of death.

Epidiolex is the first FDA approved drug to treat Dravet syndrome, whereas there are a number of other approved drugs to treat Lennox-Gastaut syndrome. In all three clinical trials with epileptic patients, Epidiolex successfully reduced the frequency of seizures. 

Though Epidiolex has got the green light from the FDA, GW Pharma won't be able to launch the drug immediately due to the presence of cannabidiol.  It’s classified under the Schedule I category which includes drugs with no therapeutic value but a huge probability of abuse. Hence GW Pharma expects the DEA to reschedule within 90 days. The FDA clearly warned that the approval of Epidiolex doesn’t mean that other cannabidiol substances are approved.

Epidiolex is currently under review in Europe. A ruling on Epidiolex can be expected in early 2019.  

Sativex is another GW Pharma product containing cannabis components for the treatment of multiple sclerosis-related spasticities and is now in its phase 3 trial for approval in the U.S. GW Pharma also has cannabinoid based medical drugs for schizophrenia, glioblastoma amongst others, currently in the pipeline.

By Ddu