Acadia Pharmaceuticals Initiates Pivotal Phase 3 Study of Carbetocin (ACP-101) for the Treatment of Hyperphagia in Prader-Willi Syndrome
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the initiation of the Phase 3 COMPASS PWS study evaluating the efficacy and safety of carbetocin nasal spray (ACP-101) for the treatment of hyperphagia in Prader-Willi syndrome (PWS).
- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the initiation of the Phase 3 COMPASS PWS study evaluating the efficacy and safety of carbetocin nasal spray (ACP-101) for the treatment of hyperphagia in Prader-Willi syndrome (PWS).
- “Essentially all experience hyperphagia, feeling a near-constant state of hunger, as though their body is telling them that they are starving, despite being actually well-nourished.
- The primary efficacy endpoint of the study is change from baseline to week 12 on the hyperphagia questionnaire for clinical trials (HQ-CT) score, a caregiver assessment for hyperphagia-related behaviors.
- Participants who complete the Phase 3 study will be eligible to enroll in a long-term, open-label extension study designed to investigate the safety and tolerability of long-term treatment with ACP-101.