WASHINGTON – US health regulators UU They approved the first prescription drug made with marijuana on Monday, a milestone that could spur further investigation into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.
and the Drug Administration approved the drug, called Epidiolex, to treat two rare forms of epilepsy in patients aged 2 years and older. But it's not exactly medical marijuana.
Strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant, but it is not the one that puts users in an elevated position. It is not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.
The British drug manufacturer GW Pharmaceuticals studied the drug in more than 500 children and adults with difficult-to-treat seizures, overcoming numerous legal obstacles that have long hampered research on cannabis.
FDA officials said the drug reduced seizures when combined with older medications for epilepsy. FDA chief Scott Gottlieb said his agency had supported research on cannabis-derived products "for many years."
"This approval serves as a reminder that solid development programs that properly evaluate the active ingredients contained in marijuana can lead to important medical therapies." Gottlieb told reporters.
The FDA has approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV.
Epidiolex is essentially a pharmaceutical grade version of CBD oil, which some parents already use to treat children with epilepsy. The CBD is one of the more than 100 chemicals found in marijuana. It does not contain THC, the ingredient that gives marijuana its mind-altering effect.
Doctors say it is important to have a consistent and government-regulated version.
"I am really happy to have a product that will make it much cleaner and one that I know what it is," said Dr. Ellaine Wirrell, Mayo Clinic program director for childhood epilepsy. "In artisbad products there is often a great variation in the doses from bottle to bottle depending on where it is obtained".
Side effects of the medication include diarrhea, vomiting, fatigue and trouble sleeping.
Several years ago, Allison Hendershot considered moving her family to Colorado, one of the first states to legalize marijuana and the home of a large network of producers and suppliers of CBD. Her 13-year-old daughter, Molly, has suffered severe seizures since she was 4 months old. But then Hendershot found out about an Epidiolex test at New York University.
"I preferred this to some of those other options because it's a commercial product that has gone through rigorous testing," said Hendershot, who lives in Rochester, New York. York
Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer "falling" seizures, in which her entire body limps and collapses.
CBD oil is currently sold online and specialty stores throughout the United States, although its legal status remains murky. Most producers say that their oil is made from hemp, a cannabis family plant that contains little THC and can be grown legally in various states for clothing, food and other uses.
The immediate impact of Monday's approval on these products is unclear.
Gottlieb of the FDA warned about the use of CBD products with "unproven medical claims".
"The promotion and use of these non-approved products may prevent some patients from accessing appropriate and recognized therapies to treat serious diseases and even fatal diseases," said Gottlieb.
The FDA previously issued warnings to CBD producers who claimed that their products could treat specific diseases, such as cancer or Alzheimer's. Only products that have received formal approval from the FDA can make such claims, which usually require clinical trials that cost millions.
Most CBD producers circumvent the problem by making general statements about general health and well-being.
Industry supporters downplayed the impact of FDA approval.
"I do not know a mom or dad in their right mind who is going to change what is already working," said Heather Jackson, executive director of Realm of Caring, a charity that supports access to the CBD. . "I really do not think it's going to affect us too much."
Jackson's group estimates that the typical family that uses CBD to treat childhood epilepsy spends about $ 1,800 per year on the substance.
A spokeswoman for GW Pharmaceuticals said the company does not immediately announce the price of the drug, which it hopes to launch in the fall. Wall Street badysts predicted that it could cost $ 25,000 per year, with annual sales reaching $ 1 billion.
For their part, the executives of GW Pharmaceuticals say they are not trying to alter the products that are already on the market. The company has promoted legislation in several states to make sure that its medicine can be sold and legally prescribed.
FDA approval for Epidiolex is technically limited to patients with the Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few effective treatments. Patients experience frequent and severe seizures, in some cases more than 100 per day.
But doctors will have the option to prescribe it for other uses.
The new drug enters an increasingly complicated legal environment for marijuana.
Nine states and the District of Columbia legalized marijuana for recreational use. Another 20 states allow medical marijuana, but the US government does. UU It continues to clbadify it as a controlled substance without medical use, in the same category as heroin and LSD.
Despite growing acceptance, there is little rigorous research on the benefits and harms of marijuana. Last year, a group commissioned by the government concluded that the lack of scientific information about marijuana and CBD represents a risk to health public.
Before Epidiolex sales can begin, the Drug Enforcement Administration must formally reclbadify the CBD into a different category of drugs than have federal medical approval. That decision is expected within 90 days.
GW Pharmaceuticals manufactures the drug in the UK from cannabis plants that are specially grown to contain high levels of CBD. And the company plans to continue importing the drug, bypbading the onerous regulations of the United States on the manufacture of restricted substances. European approval is expected in early 2019.
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This story has been corrected to reflect that Realm of Caring is not affiliated with Colorado-based CW Hemp.
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