The US Food and Drug Administration (FDA) has granted clearance to NLS Pharmaceutics to begin Phase III programme of Quilience (Mazindol ER) for the treatment of narcolepsy.
Starting this summer at various sites across US, the programme will include two double-blind Phase III trials NLS-1031 and NLS-1032.
Both the studies will enrol 50 subjects each with at least 18 years of age and diagnosed with narcolepsy with cataplexy.
Measurement of the weekly cataplexy episodes over eight weeks of treatment is the primary endpoint of the studies.
A 12-month open-label extension (OLE) study is also planned where patients from both the studies can participate, upon completion.
NLS Pharmaceutics CEO Alex Zwyer said: “Today’s announcement builds on our commitment and focus to awaken a brighter future for patients with rare and complex central nervous system diseases.”
Quilience also met all primary and secondary endpoints in the company’s randomised Phase II trial showing continuous improvement after rolling over into the OLE study.
The OLE study demonstrated comparable results in patients who subsequently received Mazindol ER versus placebo.
Quilience is an extended-release mazindol (mazindol ER) formulation and is under development to treat narcolepsy, and potentially other sleep-wake disorders such as Idiopathic Hypersomnia.
Mazindol is a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist.