The US Food and Drug Administration announced today, Monday June 25, the approval of the country's first marijuana-based prescription medication.
Along with the FDA's approval for EPIDIOLEX® for seizures associated with Dravet Syndrome, the approval is also indicated for another form of rare epilepsy that begins in childhood called Lennox-Gastaut syndrome.
Beyond the USA, the medicine is now under review by the European Medicines Agency for the treatment of seizures in patients with Lennox-Gastaut or Dravet syndrome. The regulator said that cannabidiol does not lead to intoxication or euphoria caused by tetrahydrocannabinol (THC), which is the main psychoactive component of marijuana. Outside the USA, this medicine is now under review by the European Medicines Agency (EMA) for the treatment of seizures associated with Dravet Syndrome and LGS.
The drug is made from purified cannabidiol, or CBD, a wondrous compound found in the cannabis plant.
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GW Pharma grows its own supply of cannabis in specialised glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.
Recent data suggests that it can potentially treat seizures, including Dravet syndrome and Lennox-Gastaut syndrome.
At the CU Skaggs School of Pharmacy, there are now a few drugs being tested - one for seizures and the other for Parkinson's tremors that are both are derived from cannabis.
"DEA is required to make a scheduling determination".
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Sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise, weakness, insomnia, sleep disorder, poor quality sleep, and infections were among the most common adverse effects seen with Epidiolex treatment. He also reaffirmed that "the FDA is committed to this kind of careful scientific research and drug development". "It's an unbelievable plant with so many different chemical compounds that can fix medical problems", Defran said. "This is the approval of one specific CBD medication for a specific use", Gottlieb said.
The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV. FDA has determined that CBD has negligible abuse potential.
But he said that won't affect Epidiolex's approval, since individual drugs often receive their own schedule. The FDA's warnings reminded these producers that only FDA-approved products that have gone through rigorous clinical trials can make such claims. As noted in the FDA's announcement approving Epidiolex, "m$3 arketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases". Supporters of the FDA's Epidiolex approval mark it as a major medical milestone, and are hopeful that this will open the doors to further research of cannabis as a medical cure for other ailments.
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