ISRAEL – The Israel Patent Office, affiliated with the Israeli Ministry of Justice, has approved NLS Pharmaceutics Ltd.’s Mazindol as a method of treatment for Attention Deficit/Hyperactivity Disorder (ADHD).
NLS Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company led by an experienced management team with a track record of developing and repurposing product candidates to treat rare and complex central nervous system disorders.
Quilience (Mazindol ER), the Company’s lead product candidate and proprietary extended-release formulation of Mazindol (Mazindol ER), is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders such as idiopathic hypersomnia (IH).
In an official statement, NLS Pharmaceutics announced that the Israeli patent covers the use of Mazindol for treatment of ADHD and associated sleep disorders and will be valid until the patent expires in 2037.
The Israeli patent also relates to Mazindol use in the treatment of conditions associated with ADHD such as uncontrollable sleepiness, reduced alertness or excessive daytime sleepiness.
Commenting on the Israeli grant of patent, Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics, said: “This patent reinforces our continued effort to build our global franchise in central nervous system disorders, in particular rare sleep disorders, with Mazindol.”
He further said that the multi-modal mechanism of action of Quilience® is highly unique and will have meaningful clinical benefits across a number of therapeutic areas.
According to the biopharmaceutical firm, a Phase 2 multi-center U.S. clinical trial evaluating Quilience® in adult subjects suffering from narcolepsy met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile.
“Quilience® recently obtained Orphan Disease Designation (ODD) from the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of narcolepsy,” NLS stated.
The Swiss-based company further disclosed that it is potentially funded through 2025, beyond the anticipated submission of its new drug application for Mazindol ER in narcolepsy that is expected in late 2024 or early 2025.
In addition, NLS confirmed that it has accelerated ongoing clinical development of Mazindol ER for the treatment of rare sleep disorders, adding that the pharmaceutical product is not currently available in Israel and has not been promoted for use in ADHD.
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