NLS Gets Orphan Drug Nod for Sleep Disorder Treatment

NLS Pharmaceutics has received Orphan Drug designation for its Mazindol product, the active ingredient in the company’s lead product candidate Quilience (Mazindol ER) for treatment of patients with idiopathic hypersomnia, a disorder of excessive daytime sleepiness and prolonged difficulty in waking.

The drug candidate was tested in a phase 2a study in participants with narcolepsy type 2 — a similar condition of impaired sleep-wake cycles. The results of that study indicated that Quilience significantly promotes wakefulness, the company said.

The FDA’s Orphan Drug designation is for drug or biological products to prevent, diagnose or treat rare diseases or conditions that affect fewer than 200,000 patients in the United States.