Avadel Pharmaceuticals plc announced the appointment of Susan Rodriguez as Chief Operating Officer, a newly created role designed to accelerate the commercial expansion of LUMRYZ, the company's breakthrough once-at-bedtime treatment for narcolepsy. The appointment comes at a critical juncture as the Dublin-based biopharmaceutical company scales operations to meet growing patient demand and prepares for potential label expansion.
Strategic Leadership Addition
Rodriguez will oversee all aspects of Avadel's commercial strategy, organizational structure, and operations, including supply chain management. "Susan is an accomplished biopharma executive with a track record of strategic leadership and excellence in commercializing innovative medicines," said Gregory J. Divis, Chief Executive Officer of Avadel. "Her expertise will be invaluable at this critical time in our launch as we scale to meet increasing patient demand for LUMRYZ in the narcolepsy community and work toward the potential expansion of our label to idiopathic hypersomnia."
The appointment reflects Avadel's commitment to maximizing LUMRYZ's commercial potential as the company establishes its market position in the sleep disorder treatment landscape. Rodriguez expressed enthusiasm about joining during this pivotal period: "I am delighted to join Avadel at this most exciting time, as the Company has advanced rapidly establishing a strong early market position with the launch of LUMRYZ and is poised to set new standards of care addressing critical unmet needs for people with sleep disorders."
Extensive Industry Experience
Rodriguez brings more than 30 years of life sciences experience to her new role, with particular expertise in rare disease commercialization. Most recently, she served as Chief Commercial Officer of Ardelyx, where she led the launches of first-in-class therapies in gastroenterology and nephrology and played a key role in advancing Ardelyx into a commercial company.
Prior to Ardelyx, Rodriguez served as Chief Executive Officer of Tolmar Pharmaceuticals, a specialty oncology company, where she established a new U.S. commercial entity, secured a market leading position for its primary oncology therapy, advanced their pipeline, and successfully launched a new rare disease therapy. Her earlier career included various commercial leadership positions across multiple divisions at Abbott and the Abbott-Takeda joint venture, TAP Pharmaceuticals. She holds both B.S. and M.S. degrees in psychology from the University of Pennsylvania.
LUMRYZ Market Position
LUMRYZ represents a significant advancement in narcolepsy treatment as the first and only once-at-bedtime oxybate therapy. The FDA approved LUMRYZ on May 1, 2023, for adults with narcolepsy, followed by approval on October 16, 2024, for pediatric patients 7 years of age and older with narcolepsy for the treatment of cataplexy or excessive daytime sleepiness.
The drug's approval was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: excessive daytime sleepiness (measured by Maintenance of Wakefulness Test), clinicians' overall assessment of patients' functioning (Clinical Global Impression-Improvement), and cataplexy attacks, for all three evaluated doses when compared to placebo.
Regulatory Advantages
The FDA granted LUMRYZ 7 years of Orphan Drug Exclusivity for both adult and pediatric narcolepsy indications due to a finding of clinical superiority relative to currently available oxybate treatments. The FDA specifically recognized that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
This regulatory protection provides Avadel with a significant competitive advantage as it works to expand LUMRYZ's market reach. The company is also exploring potential expansion of the drug's label to include idiopathic hypersomnia, which could further broaden its therapeutic applications.
Commercial Strategy Focus
Rodriguez's appointment signals Avadel's commitment to maximizing LUMRYZ's commercial potential in the sleep disorder market. "She has deep experience building and executing market leading launches and accelerating the growth of brands, including in rare diseases, which positions her as an ideal leader to support our ongoing growth and future opportunity," Divis noted.
The focus on rare disease experience is particularly relevant given narcolepsy's status as an orphan condition. Rodriguez's track record in successfully launching therapies in specialized therapeutic areas positions her to navigate the unique challenges of rare disease commercialization, including specialized distribution channels, patient access programs, and healthcare provider education initiatives.
LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS (Risk Evaluation and Mitigation Strategy) program due to safety considerations associated with sodium oxybate, which contains gamma hydroxybutyrate (GHB), a controlled substance. This specialized distribution model requires sophisticated commercial operations and supply chain management, areas where Rodriguez's operational expertise will be crucial.
