N.Y. to hold clinical trials for marijuana medication

ALBANY >> New York state is partnering with a British company to hold clinical trials for marijuana-based medication for children who have seizures that are resistant to their medicine.

An agreement was signed on Sunday between Gov. Andrew Cuomo’s administration and GW Pharmaceuticals. The state health department and the company will develop the framework for a clinical trial for a marijuana-based drug for people under the age of 18.

It will involve Epidiolex, an investigational medication that uses cannabidiol, a mari- juana extract that doesn’t get users high. It could help children with rare forms of epilepsy such as Dravet and Lennox-Gastaut syndromes.

Dravet syndrome is a rare genetic disorder typically untreatable by anti-epileptic drugs. It can be fatal. Lennox-Gastaut syndrome, another rare form of childhood-onset epilepsy, is characterized by different types of seizures multiple times a day and cognitive dysfunction. To be eligible for the trial, the children would have to show signs that their current medication is not working.

The health department is working on the framework for the protocol, which needs to be approved by the Food and Drug Administration be- fore it is enacted. A state official with knowledge of the agreement told The Associated Press on Monday they expect FDA approval relatively quickly. The official spoke on condition of anonymity because the official was not authorized to speak publicly about the agreement.

In Colorado, the Charlotte’s Web strain of marijuana, which is high in cannabidiol content, has received international attention for its effect on children with severe seizures. It also is low in the chemical responsible for most of marijuana’s psychological effects. The Realm of Caring, a non-profit organization which produces the strain, currently has 206 people on its waiting list in the United States and separate waiting lists worldwide.