NLS Pharmaceutics, a Swiss clinical-stage biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with its Phase 3 clinical program for Mazindol ER in the treatment of narcolepsy. The full study protocol, called AMAZE, was reviewed by the FDA and also received approval from the independent Institutional Review Board (IRB). This milestone allows NLS to quickly recruit clinical sites in the U.S. and provide Mazindol ER to patients with narcolepsy type 1.
The Phase 3 program, known as AMAZE, will consist of two double-blind studies involving a total of 100 adult patients with narcolepsy. The primary endpoint of these trials will be the measurement of weekly cataplexy episodes over an 8-week treatment period. Excessive daytime sleepiness will also be evaluated as a secondary objective using patient-reported outcome measures.
Following completion of the Phase 3 trials, eligible patients will have the opportunity to participate in a 12-month open-label extension study. NLS is confident that this regulatory milestone will help exped