September 3, 2025 - Avadel Pharmaceuticals plc (Nasdaq: AVDL), 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.
About the Licensing Agreement
Under the terms of the agreement, XWPharma grants Avadel an exclusive global license to develop, manufacture and commercialize valiloxybate worldwide, excluding mainland China, Hong Kong, and Macau. XWPharma will receive an upfront payment of $20 million from Avadel and is eligible to receive milestone payments associated with certain development milestones of up to $30 million. Avadel has also agreed to pay XWPharma up to an aggregate of $155 million in performance-based tiered sales milestones for first achievement of annual net sales up to $750 million. For first achievement of annual net sales exceeding $750 million and up to $3.5 billion, Avadel will pay XWPharma certain performance-based sales milestone payments equal to 10% of each of those sales milestones. In addition, Avadel has agreed to pay tiered royalties ranging from high-single digit to mid-teens, as a percentage of net sales of the licensed products, and also an additional $10 million milestone payment after the first commercial sale in the U.S. for each indication beyond narcolepsy and IH following FDA approval for same.
Avadel expects to advance its valiloxybate formulation into an initial PK study in the fourth quarter of 2025, followed by a pivotal PK trial in the second half of 2026. The program is expected to benefit from Avadel’s existing infrastructure and commercial capabilities, potentially allowing for efficient clinical and regulatory advancement via a bioequivalence pathway as well as a streamlined commercial launch, if approved.
About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. For more information, please visit www.avadel.com.
About XWPharma
XWPharma is a clinical-stage, neuroscience-focused biopharmaceutical company founded by a team of industry veterans who believe the hardest problems are the most important ones to solve. Leveraging proprietary chemistry, proven drug development and commercialization expertise, and a commitment to reshaping antiquated treatment paradigms in neuropsychiatry, XWPharma is advancing a pipeline of novel programs targeting clinically and commercially validated mechanisms, each engineered in-house for best-in-class potential, high approvability, and durable IP.
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