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WASHINGTON – US health authorities on Monday approved the first marijuana-based prescription drug, a step that could further stimulate research on a drug that remains illegal under federal law, despite increasing legalization for recreational use and medical.
The Food and Drug Administration has approved the drug, called Epidiolex, to treat two rare forms of epilepsy in patients 2 years of age and older. But it's not quite medical marijuana.
Strawberry flavored syrup is a purified form of a chemical ingredient found in the cannabis plant – but not the one that attracts users. It is not yet known why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.
British drug maker GW Pharmaceuticals has studied the drug in more than 500 children and adults with difficult-to-treat seizures, overcoming many of the legal hurdles that have long hindered cannabis research.
FDA officials said the drug reduces seizures when it is combined with older anti-epileptic drugs. FDA chief Scott Gottlieb said his agency has been supporting research on cannabis products "for many years".
"This approval reminds us that healthy development programs that properly value active ingredients in marijuana can lead to important medical treatments," Gottlieb told reporters.
The FDA has already approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in HIV-infected patients.
Epidiolex is essentially a pharmaceutical grade CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana. It does not contain THC, the ingredient that gives marijuana its psychotropic effect.
Doctors say that it is important to have a consistent version, regulated by the government.
"I'm really glad we have a product that will be much cleaner and I know what it is," said Dr. Ellaine Wirrell, Mayo Clinic Program Director for Infantile Epilepsy. "In craft products, the doses often vary from one bottle to the next, depending on where you get it.
Side effects of the drug include diarrhea, vomiting, fatigue and sleep problems.
A few years ago, Allison Hendershot envisioned relocating her family to Colorado, one of the first states to legalize marijuana and harboring an extensive network of CBD producers and suppliers. His 13-year-old daughter, Molly, has suffered severe seizures since the age of 4 months. But Hendershot has learned of the existence of an Epidiolex trial at New York University.
"I preferred this to some of these other options because it's a commercial product that has undergone rigorous testing," said Hendershot, who lives in Rochester, New York.
Since she's been given Epidiolex, Hendershot says her daughter was able to focus more and had fewer "falling" fits – in which her whole body becomes limp and collapse.
CBD oil is currently sold online and in specialty stores throughout the United States, although its legal status remains cloudy. Most growers say that their oil is made from hemp, a plant of the cannabis family that contains little THC and can be legally grown in several states for clothing, food and others. uses.
The immediate impact of Monday's approval on these products is not clear.
Gottlieb of the FDA has warned against the use of CBD products with "unproven medical claims".
"The promotion and use of these unapproved products may prevent some patients from accessing appropriate and recognized therapies to treat serious and even life-threatening illnesses," Gottlieb said.
The FDA has already issued warnings to CBD producers who claimed that their products could treat specific diseases, such as cancer or Alzheimer's disease. Only products that have received formal FDA approval can make such claims, generally requiring clinical trials costing millions.
Most CBD producers avoid the issue by making only general statements about general health and well-being.
Proponents of the industry have downplayed the impact of the FDA's approval.
"I do not know a mother or father in his good sense who will change what's already working," said Heather Jackson, CEO of Realm of Caring, a charity group that supports CBD access. "I really do not think it will affect us much."
Jackson's group estimates that the typical family using CBD to treat childhood epilepsy spends about $ 1,800 a year for this substance.
A spokeswoman for GW Pharmaceuticals said that the company would not immediately announce a price for the drug, which it should launch in the fall. Wall Street analysts have already predicted that it could cost $ 25,000 a year, with annual sales eventually reaching $ 1 billion.
For their part, GW Pharmaceuticals executives say that they are not trying to disrupt the products already on the market. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.
The FDA's approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few effective treatments. Patients experience frequent and severe attacks, in some cases more than 100 per day.
But doctors will have the opportunity to prescribe it for other uses.
The new drug enters an increasingly complex legal environment for marijuana.
Nine states and the District of Columbia have legalized marijuana for recreational purposes. Twenty other states allow medical marijuana, but the US government continues to classify it as a controlled substance without medical use, in the same category as heroin and LSD.
Despite the growing acceptance, there is little rigorous research on the pros and cons of marijuana. Last year, a government-mandated group concluded that the lack of scientific information on marijuana and CBD poses a risk to public health.
Before Epidiolex sales can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval. This decision is expected within 90 days.
GW Pharmaceuticals manufactures the drug in the United States from cannabis plants specially bred to contain high levels of CBD. And the company plans to continue importing the drug, bypassing the expensive US regulations on the manufacture of controlled substances. European approval is expected early 2019.
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Find full marijuana AP coverage here: http://apnews.com/tag/LegalMarijuana
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The Associated Press Health & Science Department receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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This story has been corrected to reflect that Realm of Caring is not affiliated with the Colorado-based company CW Hemp.
Copyright 2018 The Associated Press. All rights reserved. This material may not be published, disseminated, rewritten or redistributed.
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