An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy

Exclusion Criteria

• •Medical Conditions
• •1. Have a diagnosis of narcolepsy, secondary to another medical condition (eg, central nervous system injury or lesion)
• •2. Are currently prescribed a Xyrem regimen exceeding a dose of 9 grams nightly, or any single dose in excess of 6 grams.
• •3. Have been diagnosed with restless leg syndrome (RLS) requiring treatment other than iron supplements
• •4. Exhibit succinic semi-aldehyde dehydrogenase deficiency (SSADH)
• •5. Have uncontrolled hypothyroidism
• •6. Have a history of seizures, excluding early childhood non-pathological febrile seizures
• •7. Have a history of head trauma associated with loss of consciousness in the past 5 years, or if the event occurred more than 5 years prior to screening and the participant experiences sequelae due to the event
• •8. Show evidence of untreated or inadequately treated sleep-disordered breathing including:
• •1. Presence of clinically significant and untreated obstructive or central sleep apnea (as determined by the investigator or documented previously); or one of the following:
• •2. Apnea index (AI) \>10 if on Obstructive Sleep Apnea (OSA) treatment or untreated, or
• •3. Clinically significant hypoventilation, or
• •4. Noncompliance with primary OSA therapy Note: "Non-compliance" is defined as positive airway pressure use of \<4 hours per night on \<70% of nights (\<5 of 7 nights/week) per historical report (with investigator concurrence) of use of an oral appliance on \<70% of nights (≥5 of 7 nights/week), or receipt of an effective surgical intervention for OSA symptoms.
• •9. Experience parasomnias (eg, sleep walking, REM Sleep Behavior Disorder, etc.) considered by the investigator to negatively impact the conduct of the study. Parasomnia events associated with physical injury to the participant (or others) shall be discussed with the sponsor Medical Monitor.
• •10. Meet criteria for current major depression based on clinical interview
• •11. Have any clinically relevant medical, behavioral, or psychiatric disorder (other than narcolepsy) that is associated with excessive sleepiness
• •12. Have a history or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
• •13. Have a history or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or history or presence of another neurological disorder or surgical history that might affect the participant's safety and/or interfere with the conduct of the study, in the opinion of the investigator
• •14. Display relevant suicidality as indicated by Columbia Suicide Severity Rating Scale (C-SSRS) evaluation at screening
• •15. Display moderate to severe depression as indicated by the Participant Health Questionnaire - 9 (PHQ-9) at screening
• •16. Are a female participant who is pregnant or breastfeeding
• •Prior/Concomitant Therapy
• •17. Have undergone treatment with any prohibited central nervous system (CNS) agents, including but not limited to benzodiazepines, non-benzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, eg, diclofenac, valproate, ibuprofen, within 2 weeks prior to enrollment. Discontinuation for the purpose of study enrollment is permitted only if considered safe by the investigator and approved by the Medical Monitors.
• •Prior/Concurrent Clinical Study Experience
• •18. Received any other investigational drug within 30 days or five half-lives (whichever is longer) prior to screening, or plan to use an investigational drug (other than the study intervention) during the study.