OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Inclusion Criteria:

• Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302

• Met all entry criteria for the antecedent study

• May benefit from long-term treatment with open-label carbetocin in the judgment ofthe Investigator.

• Lives with a caregiver who understands and is willing and able to adhere tostudy-related procedures and is willing to participate in all study visits.

Exclusion Criteria:

• History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequentmigraines. A history of febrile seizures is not exclusionary.

• Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder

• History of suicide attempt or inpatient psychiatric hospitalization

• Has a clinically significant abnormality in vital signs at Baseline

• Has an average QTcF interval of >450 ms on the Baseline ECG performed before thefirst dose of carbetocin is given in the present study (i.e., the ECG performed atthe EOT visit of the antecedent study)

• Has developed a clinically significant ECG finding during the antecedent study

• Subject is judged by the Investigator or the Medical Monitor to be inappropriate forthe study due to AEs, medical condition, or noncompliance with investigationalproduct or study procedures in the antecedent study

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.