Radius Health, Inc. announced the first patient has been randomized in the Phase 2/3 pivotal study, SCOUT-015, to evaluate RAD011, a synthetic cannabidiol oral solution, for the treatment of hyperphagia and related neuro-behavioral symptoms in Prader-Willi Syndrome (PWS), a rare neuro-endocrine orphan disease which effects between approximately 20,000 and 30,000 patients in the US. The SCOUT-015 clinical study is a global randomized, double-blind, placebo-controlled study. It is a seamless Phase 2/3 design that allows for the evaluation of multiple dose groups and Intent-To-Treat efficacy analysis with both Phase 2 and Phase 3 cohorts.

Currently, 9 US sites are activated for screening and patient recruitment will continue across the US and globally as non-US sites are activated. RAD011 has Orphan Drug Designation and has been granted Fast Track by the U.S. Food and Drug Administration (FDA).