The FDA Approves The First-Ever Cannabis Medicine For Prescription

by Jared Lewis June 27, 2018, 2:07
The FDA Approves The First-Ever Cannabis Medicine For Prescription

But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.

The FDA news signals that the DEA will likely adjust its scheduling for CBD, which is now a Schedule I substance, denoting high potential for abuse and no medical applications.

"The FDA approval for cannabidiol is a landmark in American medicine", said Orrin Devinsky, MD, of New York University Langone Health, who helped lead the product's major clinical trials.

The drug's approval permits its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment. Cannabis-derived CBD products are available where recreational marijuana is sold, though CBD derived from industrial hemp faces fewer regulations and is even stocked by some grocery stores. Other companies working with cannabidiol include AXIM Biotechnologies and Cure Pharmaceutical. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.

US health regulators have approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law.

Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to now approved drugs.

For those who have long argued that cannabis offers medical benefits, the FDA approval represents a milestone, "a recognition that the plant is a rich source of compounds which have potential therapeutic activity", Justin Gover, chief executive of GW Pharmaceuticals, the London-based company that developed the drug, said in an interview last week. The non-intoxicating compound now falls in line with marijuana, which has "no now accepted medicinal use" in the eyes of Uncle Sam.

"I hope patients have conversations with their physicians about whether this product (Epidiolex) provides them with treatment they have been looking for with other unapproved products", said Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research.

There have been several national news stories about parents exploring the treatment and it's worked.

Some experts believe the anticipated approval will likely open the floodgates for product demand of other CBD products, and place further pressure on the FDA to move it along and approve other CBD-based medications. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy.

Federal agencies have 90 days to determine the scheduling of Epidiolex.

A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward. "This is how sound medical science is advanced".


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