FDA gives positive review for GW Pharmaceuticals’ cannabis-based medicine Epidiolex

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FDA gives positive review for GW Pharmaceuticals’ cannabis-based medicine Epidiolex

Bethan Rose Jenkins, Cannabis News Writer/Editorial

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Epidiolex, a cannabis-based treatment for epilepsy from GW Pharmaceuticals, received a positive review from staff at the Federal Drug Administration (FDA) on Tuesday.

GW Pharmaceuticals provided “substantial evidence” to prove the drug’s suitability for treating two rare types of epilepsy.

“Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with LGS [Lennox-Gastaut syndrome] and DS [Dravet syndrome,]” the agency declared in a report.

What is Epidiolex?

Related imageA purified type of cannabinoid extracted from the cannabis plant, Epidiolex has been tried and tested on children with epilepsy in numerous trials.

Preclinical and clinical data proves that Epidiolex does not have the potential to cause addiction or abuse. It does not interact with cannabinoid receptors, making it one of the most interesting products on the market right now.

One such trial was the phase 3 LGS trial, which saw patients being treated with an average of nine anti-epileptic drugs prior to being treated with Epidiolex.

Each syndrome usually arises in childhood. More difficult to treat than other types of epilepsy, the treatment-resistant syndromes were treated effectively using GW’s cannabis-based medicine. Epidiolex has a confirmed PDUFA date, or deadline for the FDA to approve the new drug, on June 27.

Should the cannabis-based medicine be approved, other companies in the biotech sector will have a much simpler experience filtering their products into the blossoming medical cannabis market.

“Epidiolex, if approved, will mark a sea change in the acceptability of cannabinoids as therapy,” the CEO of GW Pharmaceuticals, Justin Gover, told Bloomberg.

A fine example of a clinical-stage pharmaceutical company that could also gain approval if Epidiolex does is Therapix. Focused on treating people with Tourette’s syndrome, this specialty pharmaceutical company develops unique cannabinoid technologies that can be used safely for the treatment of central nervous system disorders.

Sativex is another product developed by GW. Patients with spasticity caused by multiple sclerosis are seeing positive results from using this cannabis-based treatment.

Currently, it is being marketed outside of the U.S. Included in its pipeline are candidates for schizophrenia and glioblastoma.

Epidiolex is not available in Colorado’s pharmacies

https://www.thepharmaletter.com/article/edison-increases-valuation-of-gw-pharmaceuticals-amid-epidiolex-trial-in-dravet-syndrome

Sativex

Considering the fact that an average of 33,221 pounds of cannabis flower is sold to cannabis consumers in Colorado every month, you would think that Epidiolex would be easily accessible, right?

Wrong.

Despite the fact cannabidiol (CBD) is available to purchase in health stores throughout the state, Colorado’s cannabis laws prevent pharmacies from selling the cannabis compound.

Things could be looking up, however, with a bill titled “Food and Drug Administration Cannabidiol Drug Use” recently being passed by a House committee in a 9-0 vote.

Currently, a bill is making its way through the House and, if approved, GW’s CBD-based Epidiolex medicine could be prescribed and sold in statewide pharmacies.

“We in no way intend to limit or affect access to any marijuana, recreational or medical, or any hemp products licensed in Colorado,” said GW spokeswoman Jessica Wolfe during a discussion with the House Public Health Care & Human Services Committee on Tuesday, March 21, 2018.