New cannabis-based epilepsy drug showing 'promise' in clinical trials on children

News

New cannabis-based epilepsy drug showing 'promise' in clinical trials on children

17 October 2014

A new cannabis-based drug for children with severe epilepsy is showing “promising” signs in clinical trials.

Epidiolex is being tested on children with Dravet Syndrome and other forms of epilepsy that do not respond to existing drugs.

Its manufacturer, GW Pharmaceuticals, said most of the 60 children in the trials so far had seen the frequency of both “drop” and convulsive seizures fall.

The most common side effects were somnolence (sleepiness) and fatigue in a fifth and a tenth of patients respectively.

Dr Elizabeth Thiele, director of the Pediatric Epilepsy Program at Massachusetts General Hospital, said she was “very encouraged” by the preliminary results.

“I believe that Epidiolex has the potential to be an important advance in treatment for these treatment-resistant children and will likely have a significant role as a future therapy,” she added.

The drug, which does not have any intoxicating effects, is a liquid made of a purified cannabidiol extracted from marijuana plants grown under licence at a secret location in Britain.

The US Food and Drug Administration fast-tracked the drug’s status to allow the trials earlier this year and placebo-controlled clinical trials for Dravet Syndrome and Lennox-Gastaut Syndrome are due to start.

Both forms of epilepsy start in childhood and are difficult to treat.

Out of 151 patients in safety testing for the drug, 26 experienced serious adverse effects and two died, although GW Pharmaceuticals said independent investigations found they were unrelated to the trial.

Click here to read the full article.

Keep up-to-date with drug policy developments by subscribing to the IDPC Monthly Alert.