Preliminary data suggest potential bioequivalence to Avadel’s FDA-approved once-nightly oxybate LUMRYZ, supporting a possible streamlined regulatory path. Avadel is the marketer of LUMRYZ (sodium oxybate), which is US Food and Drug Administration (FDA) approved for people ages 7 and older with narcolepsy, a once-nightly treatment for cataplexy and excessive daytime sleepiness. Valiloxybate has been designed to deliver the therapeutic benefits of oxybate therapy through a once-at-bedtime, salt-free, and artificial sweetener-free formulation. “The broad adoption of LUMRYZ demonstrates the transformative benefits that a once-at-bedtime oxybate therapy can bring to patients and their families,” says Greg Divis, CEO of Avadel Pharmaceuticals, in a release. While sodium sensitivity can affect a small proportion of these patients, all patients deserve the benefit of personalized care and the option of a no sodium, once-at-bedtime dosing solution.