Swiss clinical-stage pharmaceutical company NLS Pharmaceutics Ltd has received US Food and Drug Administration (FDA) authorization to proceed with the phase 3 AMAZE program for Quilience (mazindol ER) for narcolepsy treatment.
The AMAZE Program will encompass two double-blind phase 3 trials investigating mazindol ER versus placebo in adult patients with narcolepsy, commencing this summer at multiple sites in the US.
Both phase 3 trials, NLS-1031 and NLS-1032, will measure the weekly cataplexy episodes as the primary endpoint over eight weeks of treatment. Patients who complete these studies will be offered participation in a 12-month open-label extension (OLE) study. To be eligible for enrollment into the program, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy.
“We thank the FDA for the approval of this clinical program to evaluate Quilience in chronically ill patients suffering from narcolepsy, and we are thrilled to start recruiting for the US clinical trial this summer. Today’s announcement builds on our commitment and focus to awaken a brighter future for patients with rare and complex central nervous system diseases,” says Alex Zwyer, CEO of NLS, in a release.
NLS previously reported on the phase 2 study results in narcolepsy in which Quilience met all primary and secondary endpoints. Patients treated with mazindol ER in the randomized phase 2 trial showed continued improvement after rolling over into the OLE study, and patients treated with placebo in the randomized phase 2 trial and who subsequently received mazindol ER in the OLE study achieved comparable results to the mazindol ER-treated patients in the phase 2 trial. Data from the phase 2 studies will be presented at SLEEP 2023.
“We are pleased that the FDA has approved our clinical development plan in narcolepsy patients. We believe that the FDA’s approval affirms the company’s path to securing approval for mazindol ER in order to treat a life-long chronic disorder with high unmet medical needs,” says George Apostol, chief medical officer, in a release.
A proprietary extended-release formulation of mazindol (mazindol ER), Quilience is being developed for the treatment of narcolepsy and potentially other sleep-wake disorders such as idiopathic hypersomnia, for which NLS recently obtained Orphan Disease Designation from the FDA and the European Medicines Agency.