NLS Pharmaceutics completes OLE study with Quilience for narcolepsy

NLS Pharmaceutics announced the completion of the POLARIS six-month open-label extension study with Mazindol ER in patients with narcolepsy. POLARIS NLS-1022 OLE is an open-label extension clinical study of Mazindol ER in patients with narcolepsy type 1 or narcolepsy type 2 who completed participation in the previously reported POLARIS NLS-1021 Phase 2 clinical study, a four-week, randomized, double-blind, placebo-controlled, multi-center U.S. clinical study in 67 patients with NT1 or NT2. All patients who completed the POLARIS Phase 2 study were eligible to participate in the OLE and continue once-a-day treatment with Mazindol ER for up to six months as monotherapy. The objectives of the NLS-1022 study are to evaluate the long-term safety and tolerability of Mazindol ER and to evaluate its long-term therapeutic effect in the treatment of Excessive Daytime Sleepiness and cataplexy. Previously shared interim OLE data showed that patients treated with Mazindol ER in the randomized double-blind Phase 2 study continued to improve after rolling into the OLE study and that patients treated with placebo in the randomized Phase 2 study who received Mazindol ER in the OLE study achieved comparable results to patients treated with active drug in the Phase 2 study. Those results demonstrated further improvement in efficacy of Mazindol ER in the treatment of EDS and cataplexy with longer treatment duration as a potential first in class monotherapy. Safety and tolerability of Mazindol ER were shown to be similar between the double-blind and OLE studies. NLS Pharmaceutics plans to have the complete results of the OLE study in the first quarter of 2023 and to present these results at a future scientific meeting.