For immediate release: August 12, 2021
The U.S. Food and Drug Administration today approved a new indication for Xywav for the treatment of idiopathic hypersomnia (IH) in adults. IH is a rare chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night’s sleep. Xywav (Calcium, Magnesium, Potassium, and Sodium Oxybate) oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy aged seven and over.
“A new indication for Xywav is important because the FDA never approved idiopathic hypersomnia,” said Eric Bastings, MD, associate director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research. “Idiopathic hypersomnia is a lifelong condition and the approval of Xywav will be instrumental in managing symptoms such as excessive sleepiness and difficulty waking up and in effectively treating this debilitating disorder.”
The effectiveness of Xywav was assessed in a double-blind, placebo-controlled, randomized, discontinuation study in 154 adult patients (aged 19 to 75 years) with IH. In the clinical trial, patients randomized to switch from Xywav to placebo experienced worsening symptoms of drowsiness and IH compared to patients randomized to continue treatment with Xywav.
In the IH clinical study, the most common side effects observed in the study as a result of treatment were nausea (21.4%), headache (16.2%), dizziness (11.7%), anxiety (10, 4%) and vomiting (10.4%). %).
Xywav has a warning of central nervous system depression and abuse and abuse. The active component of Xywav is oxybate, also known as gamma-hydroxybutyrate (GHB), a List I controlled substance. Abuse or abuse of illegal GHB has been linked to serious side effects such as seizures, breathing difficulties, changes in alertness, coma, and death . Clinically significant respiratory depression and decreased alertness have occurred in adult patients taking sodium oxybate.
Because of the potential risks associated with Xywav, it is subject to strict safety controls when prescribing and dispensing it through a program called the Risk Evaluation and Mitigation Strategy (REMS).
In particular, according to the Xywav REMS, it can only be prescribed by a certified prescribing doctor and only given to a registered patient by a certified pharmacy. Only a certified pharmacy that ships directly to patients can dispense Xywav. Xywav will not be available in pharmacies.
The FDA has given this application the names Fast Track and Priority Review. Xywav also received orphan drug status, which provides incentives to support and promote drug development for rare diseases. The FDA approved Xywav for Jazz Pharmaceuticals plc.
The FDA, an agency of the US Department of Health, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of our country’s food supplies, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.
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December 8th, 2021