FDA Approves a New Low Sodium Therapy for Narcolepsy/Cataplexy

According to a story from Medscape, the US Food and Drug Administration (FDA) has recently approved a new oral solution as a treatment for symptoms associated with narcolepsy, a rare sleep disorder. This solution consists of potassium, calcium, magnesium, and sodium oxybates (marketed as Xywav) and was formulated by Jazz Pharmaceuticals. The solution is cleared for use in patient seven years or older.

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.

Improving Patient Health

The new solution was approved following the results of a clinical trial which included a total of 201 patients. In this phase 3 study, Xywav was able to reduce the number of weekly cataplexy attacks and also improved scores on the Epworth Sleepiness Scale.

While the new solution does not necessarily offer greater efficacy compared to other medications such as Xyrem (also developed by Jazz Pharmaceuticals), Xywav was designed specifically with a new formula that contained less sodium oxybate compared to Xyrem, 92 percent less in fact. While Xyrem can be an effective treatment for nacrolepsy patients, the high levels of sodium raised concerns about excessive intake when using it. 

Many Americans already consume too much sodium on a regular basis, and it can be a challenging ingredient to cut out of one’s diet. Too much sodium has been linked to elevated blood pressure and is considered a risk factor stroke and heart disease. The approval of Xywav will make it easier for patients to control their intake of sodium.


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