0595 Long-term efficacy on cataplexy attacks and excessive daytime sleepiness in open-label extension study (NLS-1022) of mazindol ER

Abstract Introduction Mazindol ER (extended-release), the first partial orexin-2 receptor agonist and triple mono-aminergic reuptake inhibitor, has demonstrated efficacy safety in significantly reducing excessive daytime sleepiness (EDS) cataplexy attacks narcolepsy type 1 (NT1) 2 (NT2) patients (POLARIS, Study NLS-1021). This was further studied an open-labeled extension (OLE) study (ClinicalTrials.gov Identifier: NCT04923594). Methods A multicenter, 6-month, OLE with 51 previously enrolled a double-blind mazindol study. Patients were administered 3mg once daily morning. Narcolepsy symptoms adverse events recorded. Safety measures included monthly physical laboratory examinations. The primary measure change from baseline EDS using Epworth Sleepiness Scale (ESS). Secondary weekly attacks, overall disease severity as rated by investigators (Clinician Global Impression of Severity) (Patient Severity). Results at 3 mg once-daily doses, produced improvements within 1-2 weeks starting dosing. Reported diminished (p < 0.001); significant decreases multiple function. Adverse generally mild showed no evidence tolerance. Conclusion is convenient, safe, well-tolerated effective treatment for narcolepsy. Its anticataleptic wake-promoting effects indicate that it may be new therapeutic option NT1 or NT2 similar better than various combinations treatments currently available. Support (if any) NLS Pharmaceutics