FDA Grants Orphan Drug Status to Narcolepsy Treatment

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.

For more information visit NLSpharma.com.