FDA to Accept New Drug Application for Narcolepsy Treatment

According to a story from Sleep Review, the drug company Jazz Pharmaceuticals plc has recently filed a New Drug Application (NDA) for its investigational treatment JZP-258, which is being developed as a low sodium alternative to sodium oxybate (Xyrem). JZP-258 will be used as a treatment for excessive daytime sleepiness and/or cataplexy in narolepsy patients aged seven years or older. The US Food and Drug Administration (FDA) has accepted the NDA with Priority Review.

About Narcolepsy

Narcolepsy is a neurological disorder that affects sleep. Patients with narcolepsy have a decreased ability to regulate their cycles of sleeping and wakefulness. The exact cause of narcolepsy is not well known. There are a number of risk factors for the condition however, such as family history, exposure to pesticides, or prior brain injury, such as a stroke or tumor. The most well known symptom of narcolepsy is excessive sleepiness during the day, often to the extent that a patient may fall asleep suddenly during their regular activities. This can occur even after a full night of sleep; patients are unable to sleep as deeply as an unaffected person. Other symptoms include cataplexy, hallucinations, sleep paralysis, insomnia, and unexpected weight gain. There is no cure for narcolepsy. Treatments for the condition include stimulants such as amphetamines and modafinil. Most patients cannot control their symptoms entirely. To learn more about narcolepsy, click here.

Reducing Long-Term Risks for Patients

The goal date set for the FDA to make its approval decision in regards to JZP-258 is July 21, 2020. JZP-258 was primarily developed due to health concerns associated with the long term use of Xyrem. Excess intake of sodium is linked to health problems such as elevated blood pressure and an increased risk of cardiovascular disease. The use of JZP-258 is expected to reduce the daily sodium intake of narcolepsy patients by as much as 1500 mg.

Narcolepsy is associated with a higher risk of health problems such as diabetes, obesity, high blood pressure, and dyslipidemia. However, the use of JZP-258 should ultimately serve as a healthier choice for these patients in the long term. 


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