Posted by Michael Wonder on 15 Mar 2018
Ovid Therapeutics announces OV101 granted fast track designation by U.S. FDA for treatment of Fragile X syndrome
15 March 2018 - Second fast track designation for OV101 within three months.
Ovid Therapeutics today announced that the U.S. FDA has granted fast track designation to OV101 for the treatment of Fragile X syndrome.
Ovid recently announced successful completion of a Phase 1 pharmacokinetic and safety study in patients with Fragile X syndrome and Angelman syndrome, demonstrating that OV101 has a similar safety and tolerability profile in adolescents as in young adults. These results will inform dosing in future clinical trials and support advancing the development of OV101 for the treatment of adolescents with Fragile X syndrome.
