NLS Pharma announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for mazindol for the treatment of narcolepsy.

Narcolepsy is a chronic, debilitating neurological disease commonly presenting with excessive daytime sleepiness, fragmented nighttime sleep, sleep paralysis and cataplexy. The disorder is often under-recognized and under-diagnosed, with around 150,000−200,000 Americans suffering from the disease but only about 50,000 currently being diagnosed. 

In addition to narcolepsy, the drug is also being investigated in a Phase 2 clinical trial for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults.

Mazindol, a wake-promoting agent, is a norepinephrine and dopamine reuptake inhibitor.

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