To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS
Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.
Current status: ENROLLING BY INVITATION.
ACADIA Pharmaceuticals (ACAD) is the sponsoring company for this trial. BiotechSign currently grades this company B (77/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.