Symptoms of narcolepsy (including cataplexy) typically develop. There is no cure for cataplexy or narcolepsy.
Last year, Jazz Pharmaceuticals’ Sunosi (solriamfetol) was approved to improve wakefulness in adults with narcolepsy or obstructive sleep apnoea. Treatment and Medication Options for Cataplexy. The new indication adds to Wakix’ use in a market dominated by older drugs such as modafinil for improving wakefulness, and others treating cataplexy attacks such as sodium oxybate and venlafaxine. Last year, the FDA rejected Wakix for the additional use.Īfter receiving the Complete Response Letter rejecting Wakix for cataplexy, Harmony met with the FDA who agreed to review a new analysis of the HARMONY1 trial.įollowing review of the data, the agency acknowledged it showed a statistically significant reduction in the rate of cataplexy for Wakix compared with placebo. Effects can be severe and cause knee buckling or the body to collapse. Treatment Narcolepsy is a rare long-term brain condition that can prevent a person from choosing when to wake or sleep. It is the only FDA-approved drug to treat cataplexy associated with narcolepsy not scheduled as a controlled substance by the US Drug Enforcement Administration.Ĭataplexy is a temporary loss of muscle tone and often triggered by strong emotions such as excitement or laughter. Wakix (pitolisant) was first approved in August 2019 for treatment of excessive sleepiness in adults with narcolepsy. It has originally been, and still is now, widely considered as an abnormal manifestation of rapid eye movement (REM) sleep during wakefulness due to the typical muscle atonia. Harmony Biosciences has scored an expanded use for its Wakix narcolepsy drug to include cataplexy – a symptom of the sleep disorder that can cause total body collapse. Cataplexy is the pathognomonic and the most striking symptom of narcolepsy.
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