Avadel Pharmaceuticals plc strengthens its sleep medicine portfolio through an exclusive license agreement with XWPharma Ltd to develop and commercialize valiloxybate, a GABA B receptor agonist, for sleep disorders treatment.
Valiloxybate offers a salt-free, artificial sweetener-free, once-at-bedtime oxybate formulation for narcolepsy and idiopathic hypersomnia.
The agreement includes an upfront payment of $20 million to XWPharma with potential milestone and royalty payments based on future net sales.
Innovative Treatment Addition
Valiloxybate provides an innovative once-at-bedtime, salt-free, and artificial sweetener-free formulation for narcolepsy and IH treatment.
Financial Aspects
XWPharma receives $20 million upfront with additional milestone payments and royalties based on sales milestones and net sales percentages.
Development Timeline
An initial PK study is set for Q4 2025, with a pivotal PK trial planned for the second half of 2026 to advance the valiloxybate formulation.
- Avadel's acquisition of the exclusive license for valiloxybate expands its potential in the sleep disorder medication market.
- The salt-free, once-at-bedtime formulation addresses specific patient needs, potentially increasing treatment adherence and outcomes.
- The agreement's financial structure with milestone payments and royalties demonstrates confidence in valiloxybate's market potential.
Avadel's collaboration with XWPharma marks a significant step towards enhancing the treatment options for sleep disorders, showcasing innovative solutions for patients' needs.