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Near the start of October, global biopharmaceutical company Jazz Pharmaceuticals (“Jazz”) announced positive safety and efficacy data from their Phase 3 clinical trial on Xywav. Jazz is determined to develop therapeutic solutions to patients with rare conditions — in this case, idiopathic hypersomnia, for which there are no current approved treatments. The trial sought to identify the safety, efficacy, and tolerability of Xywav for adults with idiopathic hypersomnia.

Xywav Trial

Altogether, Xywav is a combination of calcium, magnesium, potassium, and sodium oxybates. The therapy is orally administered. The Phase 3 trial evaluated data through the Epworth Sleepiness Scale (ESS). According to the ESS website:

The ESS asks the respondent to rate on a 4-point scale (0-3) their usual chances of having dozed off or fallen asleep while engaged in eight different activities that differ widely in their somnificity. The ESS specifically distinguishes reports of dozing behaviour (and estimates of SSPs) from feelings of fatigue and drowsiness/sleepiness, in the sense of ‘weariness from exertion’.

Secondary endpoints included Patient Global Impression of Change and Idiopathic Hypersomnia Severity Scale. 115 patients enrolled in the trial. At first, the study included a period of titration and optimization. Next, all enrolled patients received 2 weeks worth of Xywav. In the final 2 week period, patients received either Xywav or a placebo. Following the study, patients were able to enroll in a 24-week extension study.

Xywav was shown to be relatively safe and well-tolerated. Patients taking Xywav showed significant improvements in symptoms and drowsiness compared to those taking a placebo. In September, Xywav received Fast Track designation and Jazz hopes to submit a supplemental New Drug Application by the start of 2021. Until then, Xywav is not yet indicated for patients with idiopathic hypersomnia, but it is indicated for the treatment of narcolepsy with cataplexy.

Safety Information

Also known as JZP-258, Xywav is approved to treat narcolepsy with cataplexy in patients ages 7 or older. Xywav should not be taken with antipsychotic medications, muscle relaxants, drugs or alcohol, antidepressants with sedative qualities, opioid analgesics, benzodiazepines, or any other treatments with sedative properties.

Side effects and complications may include:

• Sleep apnea
• Confusion
• Delusions or hallucinations
• Depression and anxiety
• Fatigue
• Difficulty concentrating
• Headache
• Nausea and vomiting
• Appetite loss
• Diarrhea
• Excessive sweating
• Sleepwalking

Look here for full prescribing information.

Idiopathic Hypersomnia

Unlike narcolepsy and cataplexy, the cause of idiopathic hypersomnia, a rare sleep disorder, is not yet known. However, researchers believe idiopathic hypersomnia might be linked to a neurological cause, such as increased hypersensitivity to sedative brain chemicals. Generally, idiopathic hypersomnia begins around young adulthood. It is characterized by excessive daytime sleepiness that often interferes with a patient’s ability to live their daily lives. Idiopathic hypersomnia is also a primary condition, meaning it occurs without being caused by another medical condition. An estimated 37,000 people have idiopathic hypersomnia.

Symptoms include:

• Anxiety and irritability
• Chronic and excessive daytime drowsiness
• Feeling restless
• Difficulty reawakening
• Long naps that do not lessen drowsiness
• Appetite loss

Learn more about idiopathic hypersomnia.