FDA Grants Fast Track to Flex Pharma’s Therapy for ALS Muscle Cramps

The FDA granted a Fast Track designation to Flex Pharma’s FLX-787 to treat severe muscle cramps in ALS patients. There are currently no drugs approved in the U.S. for this condition.

The company expects to initiate additional Phase II trials this quarter, with a separate Phase II trial of primarily ALS patients currently underway in the U.S.

Flex Pharma said it expects to end an Australian Phase II spasticity study early, which included about one dozen MS patients, and hopes to deliver data in 2018.