This is a Phase 3, multi-center, open-label and randomized withdrawal study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.
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.
Axsome Therapeutics (AXSM) is the sponsoring company for this trial. BiotechSign currently grades this company D (38/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.