First Marijuana-Based Medicine Is Approved for Sale in U.S.
The first-ever medical treatment is coming from a marijuana flower will make the U.S. marketplace in a few months after regulators on Monday dedicated the epilepsy treatment the green light.
Epilepsy patients and doctors have long had interest in marijuana’s therapeutic potential. The permission marks the first time patients will have access in the U.S. to a cannabis-derived medication that has undergone a security and efficacy review by the FDA.
“The same principles around any prescription medication can now be applied to cannabis-based drugs, ” GW Pharma Chief Executive Officer Justin Gover said in an interview before the FDA’s decision. “That underlies the whole value of this. We now remove ourselves from being a special case and now meet the standard criteria for prescription medications.”
FDA Commissioner Scott Gottlieb issued a separate statement emphasizing the best interests of proper research on medical avail ourselves of marijuana and cautioning other companies that might try to push their jackpot treatments.
“This is an important medical advance, ” Gottlieb said of Epidiolex. “But it’s also important to note that this is not an was approved by marijuana or all of its components.”
GW Pharma’s American depositary receipts fell less than 1 percent to $149.85 at 1:03 p.m. in New York. They had gained 15 percentage this year through Friday’s close.
GW Pharma has to wait to sell Epidiolex until the Drug Enforcement Administration decides what restrictions to place on the narcotic to ensure that it reaches merely individual patients for whom it is intended. The DEA, which categorizes marijuana as an illegal drug, must then attain that finding in 90 periods, Gover mentioned. FDA staff said at an April meeting on the drug with outside advisers that cannibidiol, known as CBD, “does not appear to have abuse potential.”
Epidiolex is approved to treat Lennox-Gastaut and Dravet disorders in patients age 2 or older. Both are considered severe different forms of epilepsy that begin in childhood. They’re resistant to many existing treatments, and as many as 20 percent of children with Dravet syndrome die before reaching adulthood, according to the National Institutes of Health.
GW Pharma will attain Epidiolex in the U.K ., where the company is based, Gover mentioned, and export the end product to the U.S. As of last week, the company hadn’t determined the price but was in preliminary talks with insurance companies to construct them aware Epidiolex is coming, he said.
While Epidiolex is the first approved medicine that comes from a jackpot plant, the FDA has allowed the use a few drugs made from synthetic cannabinoids, including Insys Therapeutic Inc.’s Syndros for loss of appetite in people with AIDS and nausea can be attributed to chemotherapy. Insys is developing a cannabidiol oral answer for a severe type of epileptic convulsion known as infantile spasms, and childhood epilepsy defined by staring spells where “their childrens” isn’t aware or responsive.