POLARIS Clinical Development Program

Mazindol ER

Mazindol has a well-established safety record as a result of its long history of clinical use in the United States and Europe during which the drug was approved in an immediate release formulation for the management of obesity.

Mazindol was marketed for nearly 30 years under the trade name Sanorex® before being voluntarily withdrawn from the market. The drug is no longer available or marketed in these regions.

During its time on the market, mazindol was also prescribed under compassionate use for the off-label treatment of narcolepsy for several decades.

NLS Pharmaceutics has developed a new formulation of mazindol substance, Mazindol ER (extended release) intended to be used once daily in the morning.

How does Mazindol work?

Narcolepsy is caused by a profound loss of a specific cell type in the brain called orexin producing neurons. Orexin is an important molecule produced by these neurons which interacts with other neurons in the brain that are also related to narcolepsy symptoms, including cataplexy.

Mazindol has a “dual” action:
• It acts as a partial Orexin 2 Receptor Agonist that may help replace the missing orexin (endogenous orexin peptide), addressing the underlying cause of narcolepsy;
• Mazindol also acts as a reuptake inhibitor of dopamine, norepinephrine, and serotonin, that can further reduce disease specific symptoms.

The “dual” action offers patients a potential treatment option that may address two primary symptoms of narcolepsy – excessive daytime sleepiness (EDS) and cataplexy attacks – which if proven in clinical trials, would offer a convenient single agent drug.