Posted by Michael Wonder on 18 Nov 2019
Levo Therapeutics receives fast track designation from FDA for intranasal carbetocin for the treatment of Prader-Willi syndrome
18 November 2019 - Levo Therapeutics announced today that the U.S. FDA has granted Fast Track designation for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome.
Levo is currently enrolling participants in its Phase 3 clinical study of intranasal carbetocin for the treatment of PWS. The study is a multi-center, randomized, double-blind, placebo-controlled study called CARE-PWS.
The Phase 3 CARE-PWS study is currently enrolling study participants at over 20 clinical study sites throughout the United States and Canada, and Levo anticipates additional study sites opening in Australia soon.
