Health Care

FDA Approves First Cannabis-Based Drug

FDA Approves First Cannabis-Based Drug

The United States Food and Drug Administration (USFDA) on Monday approved the first marijuana-derived drug to enter the US market - a medication to treat two rare and severe forms of childhood epilepsy.

While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case.

Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use.

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy.

A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy. Others said they are anxious to try an FDA-approved product.

"This is an important medical advance", FDA Commissioner Scott Gottlieb, MD, said in a statement.

Physicians say it's important to have a consistent, government-regulated version.

Aside from Epidiolex, GW Pharma also sells Sativex-which includes components of marijuana-in 30 countries as a treatment for multiple sclerosis-related spasticity.

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The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle.

The company has not said how much the drug will cost, but Wall Street analysts have predicted it could cost $25,000 per year.

The agency approved Epidiolex, or purified cannabidiol, to treat Lennox-Gastaut syndrome and Dravet syndrome in patients 2 and older. But GW said it expects that the DEA will reschedule CBD within 90 days. Nevertheless, we're encouraged that the Epidiolex approval will bring more and more research interest and funding to cannabinoid based therapies that have the potential to provide significant changes to consumers' lives.

Both Dravet and Lennox-Gastaut are relatively severe forms of epilepsy that can be fatal, STAT News notes.

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it. From Walmart to CVS to the Mom-n-Pop drugstores still kicking it Smalltown, USA - legitimate cannabis medicine will be available in the same way as other prescription drugs.

While many of these developments remain in the early stages, the FDA's Epidiolex decision points to at least one concrete path ahead. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

The FDA's decision was not unexpected, as the proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials.


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