Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, and XWPharma Ltd. (“XWPharma”) together announced today that Avadel has entered into an exclusive global license agreement with XWPharma to develop and commercialize valiloxybate, a GABAB receptor agonist, for all indications, including the treatment of sleep disorders, such as narcolepsy and idiopathic hypersomnia (“IH”). Valiloxybate has been purposefully designed to deliver the therapeutic benefits of oxybate therapy through a once-at-bedtime, salt-free and artificial sweetener-free formulation.
“The addition of valiloxybate, the only once-at-bedtime, salt-free and artificial sweetener-free, extended-release oxybate, into our portfolio further reflects Avadel’s position as a leader in sleep medicine,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “The broad adoption of LUMRYZ demonstrates the transformative benefits that a once-at-bedtime oxybate therapy can bring to patients and their families. As an innovator in the treatment of sleep disorders, we are excited to add valiloxybate to our pipeline.”
“We are pleased to enter into this licensing agreement with Avadel, a recognized leader in the clinical and commercial advancement of once-at-bedtime oxybate therapy and the ideal partner to progress valiloxybate to market,” said James Huang, Executive Chairman of XWPharma. “We are excited for the opportunity to offer access to this innovative therapy to a broad population of those living with sleep disorders.”
“I am thrilled that Avadel is continuing to advance its mission to improve the lives of those living with hypersomnolence disorders by building on the team’s expertise in innovation and novel drug delivery system development,” said Anne Marie Morse, D.O., Director of Pediatric Neurology at Geisinger Medical Center at Janet Weis Children’s Hospital. “The plans to develop valiloxybate for the treatment of narcolepsy and IH with a once at nighttime medication delivery system grows our ability to reach and personalize care for more individuals living with these conditions.”
“Oxybates are transformational medications for people living with narcolepsy and IH, as they provide proven durable efficacy and address the 24 hour a day nature of these disorders. 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. I believe the additional option of once at bedtime no sodium valiloxybate will further expand utilization and, most importantly, benefit more patients,” continued Dr. Morse.
Source: Avadel
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