FDA

For many years, Cannabis was used as a pain relief and helps indigestion now it has pharmaceutically approved and making way for other Marijuana based treatments. This week U.S Food and Drug Administration (FDA) has approved a Cannabis derived drug but it cannot sell until Drug Enforcement Administration (DEA) made all medical test for its safe use.

The drug called Epidiolex, it treats two rare forms of Epilepsy: Dravet syndrome and Lennox-Gastaut, though Cannabis contains a specific compound cannabidiol (CBD) and it is not used to get high. It is a psychoactive compound produced by Marijuana and other Cannabis plants plus it will be the first drug based medicine to be approved by FDA. Pharmaceutical companies are not allowed to sell it until DEA reclassifies CBD and the company likely to reclassify it in the next 90 days.

“We believe there is significant demand for cannabinoid-based medicines that have gone through the regulatory process,” said the Vice president of investor relations, Steve Schultz.

An analyst at Informa Pharma Intelligence Stephanie Yip indicates that FDA had previously approved two Nausea drugs: dronabinol and nabilone which uses the synthetic version of tetrahydrocannabinol (THC). The main ingredient is strawberry flavored 99% of Epidiolex which take out from Cannabis, grown in UK pharmaceutical company. 

“Cannabis contains so many different compounds and strains, The FDA has just approved this singular product through stringent testing and doses and specific concentrations. It’s gone through rigorous clinical reviews and FDA review, but the FDA is likely to still crack down on claims made with other products,” Yip stated.

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As far as its effect is concerned, no one clearly knows how it works but it is hypothesized to influence the signaling between neurons. However, there are many products of CBD available like soap, supplements and various hair oils. But after the reclassification of Cannabis, it will make it more legalized which you can not obtain without getting a prescription from a Doctor.

“This approval is definitely going to encourage other companies to investigate compounds for different diseases, from pain to Alzheimer’s to multiple sclerosis to Tourettes’. Basically a whole spectrum of diseases,” said Yip.

It won’t available on Local dispensaries or medical stores as FDA products permissible only on pharmaceutical licensed stores.