Monday, 10 December, 2018

FDA Approves First Marijuana-Derived Drug

Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016 Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016
Gustavo Carr | 29 June, 2018, 23:48

The Food and Drug Administration (FDA) for the first time approved a drug directly derived from cannabis on Monday, Epidiolex, developed by the British GW Pharmaceuticals.

But now that CBD-containing Epidiolex has been approved, the Drug Enforcement Administration (DEA) has 90 days to reclassify CBD from something with "no recognized medical use" to a Schedule 2 or 3 drug like the ADHD medication Adderall.

The prescription formulation of Epidiolex is a highly purified cannabidiol (CBD) derived from the marijuana plant but lacking the psychoactive ingredient most people associate with marijuana. The drug, created by UK-based company GW Phramaceuticals, is also the first of its kind in anti-epilepsy medications. Last year, Azadian became the first marijuana startup to join the Johnson & Johnson JLabs Innovation network, an ecosystem created to give budding companies access to the resources and leadership they need to get off the ground. Scott Gottlieb stressed in a statement that approval of the drug wasn't a co-sign for marijuana, but just for "one specific CBD medication for a specific use". The approval comes as good news for the supporters of the drug, which is being used to treat children suffering from severe forms of epilepsy and seizures. "But it's also important to note that this is not an approval of marijuana or all of its components".

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The FDA said the action isn't an approval of overall marijuana use, even if it's meant to treat other illnesses, but pharmacists said the FDA's decision could lead to more marijuana-derived drugs. There are only a few pharmaceutical treatments for patients living with Lennox-Gastaut, no pharmaceutical options for those living with Dravet syndrome. "Lennox-Gastaut Syndrome is a devastating form of epilepsy, and despite now available FDA-approved medications and a poly-therapy approach to treatment, the majority of individuals with LGS will continue to have life-long, debilitating seizures, along with cognitive impairment and an abnormal brain waves on EEG (electroencephalogram)". The drug reduced seizures by half in 40 percent of Dravet patients participating in the trials.

Several states have legalized CBD oil for specific treatment of epilepsy or seizure disorders, but with this FDA approval of the compound, it will open up a new treatment option for patients who have struggled with mediating their symptoms.

Characterized by lengthy drug approval processes and more muted, long-term gains, GW is not going to ever top the industry for massive growth, but it is one of the more stable companies due to its size and industry. CBD is a cannabinoid that lacks the high often associated as a side-effect of recreational marijuana usage. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said. GW won't be able to market Epidiolex until the DEA reclassifies CBD.