FDA Approves First Drug Derived From Marijuana Plant
FDA Approves First Drug Derived From Marijuana Plant
US health regulators approve seizure drug made from marijuana
26 June, 2018, 15:27
The FDA just approvedEpidiolex, the GW Pharma seizure drug derived from cannabis, giving children with two rare and serious forms of epilepsy a new treatment-and companies looking to develop marijuana-based drugs a model for their own path to market. A study at the end of past year found that almost 70 percent of CBD products sold online were mislabeled. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticalsexpects to see happen within the next three months.
The FDA has approved synthetic versions of some cannabinoid chemicals found in the marijuana plant for other purposes, including cancer pain relief.
The agency, he added, remains concerned about "the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims".
Epidiolex, manufactured by GW Pharmaceuticals, is meant to treat seizures associated with two rare and severe forms of epilepsy. Carreno says that once the drug is descheduled, CBD manufacturers must register with the DEA-and that will make all the difference to the industry in the U.S. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD.
Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effect and has been cited by scientists as a potential treatment for mental health issues.
But before the medicine can hit the market in those areas, the Drug Enforcement Administration must reclassify marijuana, now a Schedule I drug, along with heroin and Ecstasy, that is described as a substance with "no now accepted medical use and a high potential for abuse".
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Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.
For now, the easiest thing for consumers to remember is that CBD from hemp is legal while CBD from marijuana is not. The drug contains only trace amounts of the psychoactive element THC and does not induce euphoria.
"I preferred this to some of those other options because it's is a commercial product that has gone through rigorous testing", said Hendershot, who lives in Rochester, New York.
That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.
Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA.
In company-sponsored clinical studies, cannabidiol reduced the frequency of patients' seizures. Others said they are anxious to try an FDA-approved product. "There's no time line or clock that starts ticking on us".
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