Wednesday, 19 September, 2018

FDA Green Lights Marijuana-Based Pharmaceutical Drug

Epidiolex a medicine made from the marijuana plant but without THC FDA approves first ever drug derived from marijuana | TheHill
Johnnie Parks | 27 June, 2018, 13:34

US health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

The FDA paid attention, and Monday approved Epidiolex, the first-ever prescription drug derived from marijuana.

The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the USA financial markets. Where is weed legal? Although a synthetic version of THC, marijuana's main psychoactive ingredient, has been legally available as a treatment for nausea and appetite loss since 1985, this is the first time the federal government has given its blessing to a medication derived directly from cannabis.

Having an FDA-approved, pharmaceutical-grade CBD drug will open up a new treatment option for epilepsy patients by delivering a high-quality, consistent dose of CBD, says Robert Carson a pediatric neurologist at Vanderbilt University who treats patients with epilepsy. Sativex hasn't been granted approval in the United States, however. The agency is expected to do so within 90 days. "Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis - a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states". 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. A bill was introduced to the House a year ago to legalize the use of marijuana, but it has yet to reach the floor for vote.

The medication, tested in three randomized, placebo-controlled trials with more than 500 patients, was effective in reducing seizures, the FDA said. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds. Both forms of epilepsy cause severe seizures.

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And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said.

Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs. This decision comes despite the fact that the US Drug Enforcement Agency lists the plant itself as a schedule 1 drug-meaning it has no recognized uses with a high potential for abuse.

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.

The commissioner also noted that his agency is "prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims". The decision caps decades of work by the company to gain approval in the USA for a medicine derived from the cannabis plant. "This is how sound medical science is advanced".

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