[ad_1]
The US Food and Drug Administration approved the first cannabis-derived drug this week, but it can not be sold until the Drug Enforcement Administration changes the classification of the specific compound used. So, what's next?
Epidiolex treats severe forms of infantile epilepsy and contains the compound cannabidiol (CBD). Although CBD comes from cannabis, it will not make people go up; it is the THC compound that is psychoactive. But since cannabis and cannabis are classified as Schedule I drugs with "no currently accepted medical use and a high risk of abuse", drug companies are not allowed to sell them to unless the DEA reclassifies the CBD
It is likely that the DEA will reclassify CBD within 90 days, says Stephanie Yin, an analyst at Informa Pharma Intelligence. (The manufacturer of Epidiolex GW Pharmaceuticals has said the same thing.) Most likely, according to Yin, it will be changed to Schedule IV or Schedule V, which are schedules that include d & # 39; other anti-epileptic and anxiolytic drugs such as Xanax and Klonopin
This does not mean that cannabis as a drug will be removed from the appendix Yin points out that the FDA has already approved two drugs for nausea – dronabinol and nabilone – that use synthetic versions of THC. The DEA has scheduled these drugs as Schedule III and II, respectively, but has not yet postponed cannabis. In addition, FDA Commissioner Scott Gottlieb said in a statement that the approval of Epidiolex "is not an endorsement of marijuana or any of its components."
If these synthetic THC drugs can be approved and postponed, the CBD can be postponed to the DEA to reprogram the cannabis itself? "Cannabis contains so many different compounds and strains," says Yin. "The FDA has just approved this unique product through rigorous testing and specific dosages and concentrations.It has gone through rigorous clinical reviews and FDA review, but the FDA should still crack down on them." claims made with other products. "
To be clear, there are already many readily available CBD products, from oil supplements to various beauty products like soap. But it's one thing to sell them as supplements, and another to sell them as drugs. "You can get vitamin C from oranges at the grocery store, or you can get a clinical vitamin C preparation to treat a disease, and these two things are treated very differently," says Chris Stubbs , scientific director of hemp culture and genetics. GenCanna company. Clinical CBD is much more strictly regulated.
However, reclassification will probably make medical cannabis more legitimate. Rite Aid, for example, has already said that she was going to fill prescriptions for Epidiolex, which should be available in pharmacies in the fall. (It will not be available at clinics because FDA-approved drugs can only be sold in locations with a pharmaceutical license.) And GW Pharmaceuticals is already studying other CBD-derived drugs to treat different forms of drugs. # 39; epilepsy. cancer and schizophrenia. "This approval will certainly encourage other companies to investigate compounds for different diseases," she says, "from pain to Alzheimer's disease to multiple-sclerosis Tourettes". Basically a whole spectrum of diseases. "
Source link