April 19, 2018
GW Pharmaceuticals, a UK-based drug manufacturer, has submitted its patent epilepsy drug to FDA for approval. The drug called , a non-sedative constituent of marijuana plant. An initial report from FDA is hinting that Epidiolex might become the first CBD drug to get the approval by the US drug regulator. The report acknowledges there is ‘substantial evidence’ regarding the efficacy of the drug.
Lennox-Gastaut and Dravet are the two most severe forms of epilepsy. Not only are they hard to treat, these two epilepsy conditions can prove to be terminal for children. The affected minors can experience dozens or even more than hundred seizures each month. Statistics reveal another unsettling fact vis-à-vis Dravet i.e. nearly 20 percent of children suffering from this acute epileptic condition die before they reach the age of maturity.
There is growing evidence that Cannabidiol helps in mitigating the effects of epilepsy. Moreover, it’s a non-psychoactive part of cannabis plant, which makes it ideal for the manufacturing of drugs particularly for juvenile patients. GW Pharmaceuticals has particularly developed Epidiolex to treat epilepsy of this cohort.
In the first phase of the study, the researchers found out that the Epidiolex could reduce the number of seizures by 40 percent in minors suffering from Dravet. Later on, the company conducted a trial of 120 patients and the results were again very encouraging in cutting down the number of seizures in patients suffering from Lennox-Gastaut and Dravet. After this study got the endorsement of epilepsy research facilities of various universities, GW Pharmaceuticals filed for the approval of FDA.
It’s important to note that FDA’s approval holds great significance for any pharmaceutical product. After getting a nod of approval from FDA, a drug has informally become a legitimate pharmaceutical product all over the world.
This influence of FDA is also demonstrated by the fact that GW Pharmaceuticals’ share price has started to rise after the regulatory body’s initial report. Pharma experts are positive that they will approve the drug for the US market. However, FDA has also pointed out some of the side effects of the drug to liver. But they also admit that these side effects are manageable. Moreover, risk-benefit profile of the drug has also satisfied the experts at FDA.
CEO of GW pharmaceuticals is hopeful that they will get FDA approval. He also thinks that this development will be huge for all CBD-derived drugs. In addition, acceptability regarding cannabis as a therapeutic substance will also be improved. If Epidiolex gets approved by FDA, then health insurance plans in the US will also cover this drug’s cost.
GW is planning to launch Epidiolex in the form of oral spray with fruity flavors for children above two years. People from FDA will discuss Epidiolex with other advisory bodies before giving the final judgment. Experts say we will find out the fate of Epidiolex by the end of June. If all things go right, Epidiolex will be the first FDA-approved drug made of completely organic marijuana plants.
Marijuana stays in the news, and Alice is always ready to keep us updated. A world traveler and lover of freedom, Alice knows what is going on, no matter where she roams. She specializes in marijuana legalization stories across the globe, with up to date... [read more]