![]() ![]() “Many patients don’t like the idea of having to wake up at night to take a second dose of the traditional or the low-sodium oxybate,” he says. It too is dosed twice nightly.įor many patients, the once-nighty dosing of new entrant Lumryz is an advantage, says Thorpy, who is also director of the Sleep-Wake Disorders Center at Montefiore and professor of neurology at Albert Einstein College of Medicine. A related option also marketed by Jazz Pharmaceuticals is Xywav, or calcium, magnesium, potassium, and sodium oxybates, which was FDA approved in 2020 and is an oxybate product with 92% less sodium than sodium oxybate. The other available sodium oxybate formulation is Xyrem, which was FDA approved in 2002 and is marketed by Jazz Pharmaceuticals. Sodium oxybate is a mainstay of narcolepsy therapy. It’s not easy to work out what the best first drug or the best combination is for a particular patient.”Īvadel’s Lumryz, which was FDA cleared in May 2023 and became commercially available in June, is an extended-release formulation of sodium oxybate taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. “But it does make it more complicated for the average physician prescribing for a patient with narcolepsy because we do have so many different types of medications available. Thorpy, MD, an investigator in Avadel Pharmaceuticals’ REST-ON phase 3 trial for Lumryz, which is the most recent narcolepsy therapy to get FDA approval. “We’re entering the stage where we’re using drugs with different activities in a particular patient to try to get the maximum improvement in their functional ability,” says neurologist-sleep specialist Michael J. Sleep specialists must understand the sometimes subtle differences and how to weigh the pros and cons for each patient. So despite the seeming multitude of options approved by the US Food and Drug Administration (FDA) recently, the sleep medicine subspecialty should expect more narcolepsy-treating drugs to continue to surface. They are taken at different times of day in different doses. The drugs treat narcolepsy symptoms-such as excessive daytime sleepiness and cataplexy-to differing degrees, with none promising full resolution. The variety of narcolepsy drugs available in the United States work through different mechanisms-GABA, histamine, and perhaps soon orexin, as well as other systems. In the increasingly verdant landscape of narcolepsy pharmacotherapy, no two drugs fill the same space. With new narcolepsy drugs available-and more in the pipeline-sleep specialists face the challenge of selecting the most suitable therapies for their patients.
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