News

Sunovion’s Oral Apomorphine Film Seen to Ease Parkinson’s Off Periods in Phase 3 Trial

Sunovion Pharmaceuticals’ apomorphine sublingual under-the-tongue film (APL-130277) — now under review for approval —  significantly improved motor fluctuations, or off episodes, in Parkinson’s patients in Phase 3 clinical trial, results show. The double-blind pivotal study, (NCT02469090), evaluated the efficacy and safety of APL-130277 as a fast-acting oral treatment for…

FDA Grants Regenerative Medicine Advanced Therapy Designation to VY-AADC for Parkinson’s

The U.S. Food and Drug Administration granted Voyager Therapeutics’ gene therapy candidate VY-AADC regenerative medicine advanced therapy (RMAT) designation for the treatment of therapy-resistant motor fluctuations in Parkinson’s patients. The RMAT designation, recently created by the FDA, is given to regenerative medicine products intended to treat, modify, reverse,…