California bill seeks exemption for first federally approved medicine made from marijuana

Assemblyman Jim Wood is attempting to clear the way for Californians to use the first federally approved medicine made from marijuana, removing a legal barrier that could stand in the way of an expected surge in cannabis-?based pharmaceuticals.

Wood, a Santa Rosa Democrat who chairs the Assembly Health Committee, authored a bill that would make a drug approved Monday by the Food and Drug Administration for treatment of two rare and severe childhood-onset epilepsies legal for California physicians to prescribe.

The two disorders - Lennox-?Gestaut syndrome and Dravet syndrome - afflict fewer than 45,000 Americans, but experts expect the drug, Epidiolex, will be prescribed for other types of epilepsy, Wood said.

Epidiolex, produced by GW Pharmaceuticals, is the first approved medicine that “contains a purified drug substance derived from marijuana,” the FDA said in a statement.

The strawberry-flavored syrup, intended for children ?age 2 and older, is a “pharmaceutical formulation of pure cannabidiol (CBD),” the manufacturer said.

CBD is a chemical component of cannabis, but does not deliver the mind-altering effects of marijuana, which come from tetrahydrocannabinol (THC). Increasingly popular for relief of stress and anxiety, CBD is the basis for an industry worth ?$200 million a year, according to the Hemp Business Journal.

Wood, the only dentist in the Assembly, said he had been hearing reports of cannabis being used to help people with epilepsy, with mixed results, and crafted his bill last year in anticipation of the new drug.

Any product that contains marijuana in any form is classified as a Schedule 1 controlled substance by both California and the federal government, Wood said.

Removal of Epidiolex from the Drug Enforcement Administration’s Schedule 1 list was expected within 90 days, GW Pharmaceuticals said. But even if that happens, California would also have to exempt the drug to make it available to physicians and the public.

“I had to do something,” Wood said, when he learned the state might have such a barrier.

“I hope FDA approval of Epidiolex opens the door to more research opportunities to tap into the uses of cannabis to see what other CBD-derived medications could help patients with any number of conditions,” he said.

His bill, AB 710, passed the state Senate and Assembly earlier this month on a combined vote of ?115-0 and is now before Gov. Jerry Brown.

The exemption would apply to any drug, for any condition, that is derived from CBD and approved by the FDA.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement.

“And the FDA is committed to this kind of careful scientific research and drug development,” he said.

Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures, the FDA said.

More serious seizures may follow, and young patients may experience poor language and motor skills development, hyperactivity and social difficulties.

Lennox-Gastaut syndrome typically involves multiple types of seizures between ages 3 and 5, and most children develop learning problems, intellectual disability and delayed development of motor skills such as sitting and crawling.

The new drug’s efficacy was tested in clinical trials involving 516 patients with either syndrome, the FDA said.

Epidiolex, taken with other medications, was “shown to be effective in reducing the frequency of seizures when compared with a placebo,” the agency said.

GW Pharmaceuticals said it is evaluating ?Epidiolex for other rare epilepsy conditions and has a “deep pipeline” of other cannabinoid compounds in trials for ?epilepsy, brain cancer and schizophrenia.

You can reach Staff Writer Guy Kovner at 707-521-5457 or guy.kovner@pressdemocrat.com. On Twitter @guykovner.