Published: Thu, June 28, 2018
Medicine | By Tracy Klein

U.S. approves first marijuana-based medicine

U.S. approves first marijuana-based medicine

Others in this classification are heroin and LSD.

FDA officials noted the significance, signaling a new approach to looking at a plant still defined in federal law as having "no now accepted medical use". According to the AP, it may stimulate more research in relation to drugs, in particular for recreational and medical use.

GW Pharma's American depositary receipts fell less than 1 per cent to US$149.85 (RM599.43) at 1.03pm in NY.

But the agency is expected to do just that. As of last week, the company hadn't determined the price but was in preliminary talks with insurance companies to make them aware Epidiolex is coming, he said.

An FDA advisory committee in April had recommended unanimously that Epidiolex be approved.

The DEA did not immediately respond to Ars' request for comment.

Because CBD is still a Schedule 1 drug - those with a high potential for abuse and no medical value - GW can not market Epidiolex until the U.S. Drug Enforcement Administration reclassifies it, which is anticipated to occur within 90 days.

Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).

Lennox-Gastaut syndrome and Dravet syndrome are both rare conditions that develop in childhood involving frequent seizures.

Before the drug can be made widely available, the US Drug Enforcement Administration must reclassify CBD, which is considered a Schedule 1 drug that has a high risk of abuse and no medical value because it is derived from marijuana. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.

"Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality and most importantly, that these products have been proven safe and effective for patients", Gottlieb added. However, the commissioner also noted that the agency is prepared to take the necessary actions should CBD-containing products with unproven medical claims get illegally marketed in the country.

He said, "Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases". Patel said the drug trials generated good information about safety and side effects of CBD use, and the FDA approval opens doors for more research on the benefits and effectiveness of CBD on other conditions.

Epidiolex is reportedly an oral solution meant to treat seizures that are known to be associated with two particular types of epilepsy, the Lennox-Gastaut syndrome, and Dravet syndrome, for children 2 years old and above.

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