A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

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• Has poorly controlled and clinically significant sleep-disordered breathing, at the most recent diagnostic PSG or at Visit 4 (in accordance with the AASM Scoring Manual [rule 1B]): a. Has AHI ≥15 per hour b. If receiving treatment for OSA, has an average AHI ≥10 per hour over the 30 days prior to Visit 1 based on the Investigator’s review of PAP unit data c. Has central apnea index >5 per hour
• Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
• Is employed by Alkermes, the CRO, or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family (ie, a spouse, parent, sibling, or child, whether biological or legally adopted) of an Alkermes, CRO, or study site employee
• Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle: a. Has symptoms of narcolepsy secondary to another medical condition (eg, central nervous system injury or lesion, craniopharyngioma, chronic fatigue syndrome) b. Has performed shift work (working nighttime hours) or is experiencing other life activities (eg, insufficient night sleep; consistently caring for a child who wakes in the night) that interfere with regular nighttime sleep in the past 30 days prior to Visit 4 c. Has an implanted hypoglossal nerve stimulation device (eg, the Inspire® Upper Airway Stimulation system) d. Has nicotine dependence that affects sleep (eg, a subject who routinely wakes at night to smoke). See Section 5.3 for restrictions during the study. e. Excessive caffeine use 1 week prior to Visit 4 or anticipated excessive caffeine use during the study, defined as >600 mg/day of caffeine. See Section 5.3 for restrictions during the study
• Has a significant cardiovascular disease during the Screening Period, or within the last 2 years, including: a. Myocardial infarction, ischemic heart disease, cardiac failure, or arrhythmia b. Atrial fibrillation or an abnormal ECG demonstrating clinically significant dysrhythmia(s), including having a corrected QTcF >450 msec if male and >470 msec if female. Left bundle branch block is not exclusionary if it is asymptomatic and is an isolated ECG finding without clinical significance, as determined by the Investigator. c. Idiopathic sinus tachycardia with a resting HR >100 beats per minute, confirmed on repeat testing within 30 minutes d. Uncontrolled hypertension with systolic BP >130 or diastolic BP >90 mm Hg during Visit 1. One retest is allowed. If the retest measurement is >130/90 mm Hg the subject may be rescreened once, but only after their BP has been stabilized and is ≤130/90 mm Hg for at least 30 days. See Section 8.3.4 for details on BP and HR collection.
• Has a major psychiatric or substance use disorder established in accordance with DSM-5, including: a. Disorders of schizophrenia spectrum (ie, schizophrenia, schizophreniform, schizoaffective disorder, acute or chronic psychotic disorder) b. Bipolar disorder c. Current or recent (within the last 6 months) major depressive episode d. Current or past (within the last 2 years) diagnosis of a moderate or severe substance use disorder e. The subject is at a current risk of suicidal behavior; or has a “Yes” to questions 4 or 5 on the C-SSRS and/or had a suicide attempt in the period within 12 months prior to Visit 1 and up to and including Visit 4