Update: Already in June, the Food and Drug Administration (FDA) approved the first drug from cannabis (marijuana). Now officially available in the US by prescription, GW Pharmaceuticals today announced a statement.
The drug Epidiolex is approved for the treatment of two rare forms of epilepsy, Dravet syndrome and Lennox-Stange syndrome. It also comes from cannabidiol (CBD), one of the main ingredients of cannabis. Unlike its more well known siblings tetrahydrocannabinol (THC), CBD does not produce a "high".
Although there are other drugs on the market based on synthetic versions of compounds contained in cannabis, this is the first product actually manufactured from the plant that is FDA-cleared and sold in the US (the plants however, are grown in an installation in the UK.)
Prior to the approval of Epidiolex, the Drug Enforcement Administration (DEA) considered all forms of CBD as a Schedule I have used drugs according to the Controlled Substances Act, a high-level drug category Abuse potential and is reserved without recognized medical use. However, upon approval of the drug, DEA announced that it would place Epidiolex in Schedule V, the least restrictive class. However, any form of drug that is not FDA-approved remains in Schedule I.
The average price for one year of Epidiolex treatment is approximately $ 32,500, CNN reports . However, GW Pharmaceuticals expects much of the cost through insurance and has initiated a program (19459018) to further fund patients.
Original Report (June 25, 2018):
In an unprecedented move, the Food and Drug Administration (FDA) has epidiolex – the first drug made from cannabis (marijuana) – to treat two Types of epilepsy admitted.
Epidiolex is specifically approved for treatment [19459006DravetSyndrome and Lennox-Gastaut Syndrome two rare and severe forms of epilepsy beginning in childhood.
However, there is a possibility that the doctor will prescribe Epidiolex off-label for other forms of epilepsy. The drug is made from cannabidiol (CBD), a non-psychoactive substance found in cannabis that does not produce the typical "high" sensation.
The drug's approval was based on three clinical trials involving 516 patients with either syndrome (as well as several additional safety studies) comparing with those taking Epidiolex to placebo recorded a decrease in seizures. The most common side effects of epidiolex were drowsiness, elevated liver enzymes, loss of appetite, diarrhea, rash, fatigue, insomnia, and infection.
"Today's approval of Epidiolex is a historic milestone that encourages patients and their families to receive the first and only FDA-approved CBD drug for the treatment of two severe epilepsies that occurred in childhood," said Justin Gover. Chief Executive Officer or GW Pharmaceuticals, in an opinion . "This approval marks the culmination of GW's longstanding partnership with patients, their families and physicians in the epilepsy community to develop a much-needed, novel drug.
Other cannabis compounds-based drugs are already on the market, z as Dronabinol (Marinol), a synthetic form of THC, the main component of cannabis used to treat nausea and vomiting that may accompany chemotherapy, but Epidiolex is the first FDA-approved drug instead of being manufactured synthetically.
According to current federal law, cannabis and all of it are derived from the plant. The plant (including CBD) is considered a drug Schedule I The federal approval of a CBD-based drug represents j but a challenge for the classification dar.
A division according to Schedule I means that according to the federal government, there is a high potential for abuse and no medical use of the drug is accepted.
"Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the marijuana plant," the press release said. "In support of this application, the company conducted nonclinical and clinical studies to assess the potential for abuse of CBD."
In addition, the press release stated that "the FDA is preparing and transmitting through the US Department of Health and Human Services a medical and scientific analysis of timed substances such as CBD and recommendations to the Drug Enforcement Administration (DEA) regarding controls within the CSA. "However, it is up to the DEA to make the final planning decision.
At this time, it is "unclear whether Epidiolex's scheduling per se will have a significant impact on CBD's scheduling," Paul Armentano, deputy director of [19459006NORML tells SELF. But "when the DEA is forced to rethink the subject of CBD planning," he predicts that CBD may enter Schedule III in a standardized, FDA-approved compound such as Epidiolex, meaning that the DEA believes is that they have a moderate to low level of potential for dependence and some medical use. (The drugs currently on Schedule III include ketamine, tylenol with codeine, and anabolic steroids, to name but a few.) However, CBD in an unauthorized product would remain in Schedule I, Armentano predicts.
This type of collapse already exists in The case of dronabinol, which is a Schedule III drug, notes Armentano. Of course, cannabis and THC are still in Schedule I.
The FDA also made it clear that CBD products that are not FDA approved continue to be severely attacked.
Trend Wellness product in recent years, which the FDA has found in terms of because it is still considered a Schedule I drug and is often labeled incorrectly or sold with promotional material that too much promises what is supposed to be beneficial ] The Epidiolex approval "reminds us that advancing sound development programs that properly evaluate marijuana-containing compounds can lead to important medical therapies, and the FDA is more careful about this scientific research and drug discovery, "said FDA Commissioner Scott Gottlieb, MD, in the press release.
"At the same time, we are ready to take action if we see the illegal commercialization of CBD-containing products with serious, unproven medica. Gottlieb continues. "Marketing unauthorized products with unsafe dosages and formulations may discourage patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases."