The US Food and Drug Administration (FDA) has reviewed the full protocol of NLS Pharmaceutics’ NLS-1031 study, which is part of the AMAZE programme examining Mazindol ER as a treatment for narcolepsy.
The Phase III AMAZE programme will include two double-blind Phase III studies designed to evaluate Mazindol ER against placebo in adults with narcolepsy.
Both studies will enrol 50 patients from various sites exclusively in the US. Enrolment is due to begin in the coming days.
Measuring weekly episodes of cataplexy over eight weeks is the study’s primary endpoint.
The trial’s secondary objectives are to measure excessive daytime sleepiness using the Epworth Sleepiness Scale (ESS) and Patient-Reported Outcomes Measurement Information System (PROMIS-SRI).
NLS Pharmaceutics chief medical officer George Apostal said: “In addition to IRB approval of the Phase III study protocol for AMAZE obtained last week, with this regulatory milestone achieved, we can recruit US clinical sites quickly and efficiently, allowing us to move forward with providing Mazindol ER to patients with narcolepsy type 1.”
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A 12-month open-label extension (OLE) study is planned to include patients who have completed both studies.
Patients aged at least 18 years old who have been diagnosed with narcolepsy associated with cataplexy are eligible to participate in the OLE study.
NLS Pharmaceutics CEO Alex Zwyer said: “We are pleased with the FDA’s review of the Phase III protocol and now expect to move quickly to begin enrolling patients in the AMAZE program in centres across the US in the coming days.”
A proprietary extended-release formulation of mazindol, Mazindol ER is used for the treatment of other sleep-wake disorders such as Idiopathic Hypersomnia.
The drug has also shown the potential to treat adult patients with attention-deficit hyperactive disorder (ADHD) in a US-based Phase II study.
Mazindol ER was found to be well-tolerated in the study, which met all its primary and secondary endpoints.