FDA Approves Harmony Biosciences' Sleep Disorder Drug

Publisher: The Insight Partners

According to the recent studies performed in the field of narcolepsy therapeutics, combination therapy has emerged as a more effective solution for sleepiness in comparison to the efficiency exhibited by a single drug. In February 2019, Harmony Biosciences received the US Food and Drug Administration’s acceptance to prioritize the review for New Drug Application for Pitolisant intended to treat the excessive daytime sleepiness among adult patients suffering with narcolepsy with cataplexy. Pitolisant is an investigational first-in-class highly selective histamine receptor agonist/inverse agonist. The drug offers a novel option to treat the condition of both EDS and cataplexy for narcolepsy. The company aims to consider histamine as a potential lead molecule and prove its efficiency in improving the sleep-wake state instability. The booming studies on narcolepsy combination drugs are likely to be under the clinical trial phases within a few years. Recently, the new drug, Wakix, was approved as treatment for excessive daytime sleepiness associated with narcolepsy.

The major driving factors are rising prevalence of sleep related neurological disorders, emerging local pharmaceutical and biopharmaceutical companies, and increasing awareness regarding neurological disorders are expected to boost the market growth over the years. However, side effects and risks associated with the narcolepsy medications and delayed diagnosis and misdiagnosis of the disease are likely to pose a negative impact on the market growth.