Pharmaceutical Company Avadel Reinforces its Sleep Medicine Offerings with Exclusive Acquisition of Valiloxybate from XWPharma Limited
In a significant move, Avadel Pharmaceuticals has entered into an exclusive global license agreement with XWPharma to develop and commercialize valiloxybate, a GABA receptor agonist, for all indications, including the treatment of sleep disorders such as narcolepsy and idiopathic hypersomnia.
Under the terms of the agreement, Avadel will receive an upfront payment of $20 million from XWPharma, with potential for additional development, regulatory, and sales milestone payments, and royalties on future net sales. This partnership marks a significant step forward in the development of a new treatment for sleep disorders.
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 licensing agreement grants Avadel an exclusive global license to develop, manufacture, and commercialize valiloxybate worldwide, excluding mainland China, Hong Kong, and Macau.
LUMRYZ, an extended-release sodium oxybate medication, is currently approved for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy, and in pediatric patients seven years of age and older with narcolepsy. Valiloxybate is designed to deliver the therapeutic benefits of oxybate therapy through a once-at-bedtime, salt-free and artificial sweetener-free formulation, offering a potentially differentiated profile from traditional oxybate therapies.
While LUMRYZ holds promise for those suffering from sleep disorders, it is important to be aware of its potential side effects. Common side effects in adults include nausea, dizziness, bedwetting, headache, and vomiting. Those with breathing or lung problems, heart failure, kidney problems, or on a salt-restricted diet may not be suitable candidates for LUMRYZ.
LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. It is crucial to take the medication exactly as prescribed by a healthcare provider. Selling or giving away LUMRYZ is illegal and may harm others.
Falling asleep quickly, including while standing or getting up from bed, can lead to falls with injuries. Anyone who takes LUMRYZ should not engage in activities that require full wakefulness for at least six hours after taking the medication.
LUMRYZ can cause serious side effects, including breathing problems, mental health problems, and sleepwalking. If you experience any of these side effects, it is essential to seek immediate medical attention. Report negative side effects to the FDA at http://www.fda.gov/medwatch or 1-800-FDA-1088.
It is always advisable to consult a doctor or pharmacist for more information about LUMRYZ or any other medication. LUMRYZ should be kept in a safe place to prevent abuse and misuse. The FDA has granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients seven years of age and older with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments.
In a separate development, Harmony Biosciences will take over the development and marketing of Xywav (calcium, magnesium, potassium, and sodium oxybates), a GABA receptor agonist used to treat sleep disorders like narcolepsy and idiopathic hypersomnia. This move further underscores the growing interest in developing effective treatments for sleep disorders.
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