On behalf of Radius Health, Inc:
Boston, Mass., July 22, 2021 — Radius Health, Inc. announced Wednesday, July 21, 2021 that it has recently received the written meeting minutes from a June Type C meeting held with the U.S. Food and Drug Administration (FDA) regarding RAD011, a synthetic cannabidiol oral solution.
RAD011 is initially to be utilized for the treatment of Prader-Willi syndrome. RAD011 has previously been granted Orphan Drug and Fast Track Designation by the FDA. Based on the feedback received, Radius plans on initiating a pivotal Phase 2 /3 global study for patients with PWS.
Paige Rivard, CEO of PWSA | USA said, “We are encouraged by Radius’ commitment to advance RAD011 for the treatment of debilitating symptoms associated with PWS, particularly hyperphagia. We look forward to supporting their team throughout their study by raising awareness of their planned study with key opinion leaders, caregivers and individuals within the PWS community, and providing a means to gather perspective of individuals with PWS and critical caregivers.”
Radius plans to initiate the pivotal Phase 2/3 study, to be branded as “SCOUT” (Synthetic Cannabidiol Oral Solution), by end of 2021 or early first quarter of 2022. With this current initiation timeline, it is
anticipated top line results would be available in the second half of 2024.
Read Radius’ full press release on this announcement by clicking here.