Summary: Avadel Pharmaceuticals announced its second-quarter results, highlighting the progress of its narcolepsy drug, Lumryz. The company initiated a phase 3 trial for Lumryz in idiopathic hypersomnia and awaits an FDA decision on its use in pediatric narcolepsy. Lumryz, approved by the FDA as a once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults, has seen growing patient demand and enrollment in support services.
Key Takeaways:
- Phase 3 Trial Initiation: Avadel Pharmaceuticals has started a phase 3 trial to evaluate Lumryz for the treatment of idiopathic hypersomnia.
- Pending FDA Decision: The FDA is expected to make a decision by Sept 7 on the use of Lumryz for treating pediatric narcolepsy.
- Growing Patient Demand: There has been a steady increase in patient demand for Lumryz, with more than 1,900 patients on the medication as of June 30.
In its second-quarter results, Avadel Pharmaceuticals reported advancements for Lumryz, including the initiation of a phase 3 trial for idiopathic hypersomnia and an upcoming decision on its use in pediatric narcolepsy.
Lumryz is an extended-release sodium oxybate medication approved by the US Food and Drug Administration (FDA) on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy.
“The continued strong quarter-over-quarter growth in patient demand is a testimonial to the reception Lumryz has received from the narcolepsy community since its launch last year. Alongside our focus on maximizing the launch of Lumrzy for the treatment of narcolepsy, creating further sustainable value through indication expansion is a priority,” says Greg Divis, chief executive officer of Avadel Pharmaceuticals, in a release. “We are driven by our commitment to provide patients suffering from sleep disorders with transformative treatment options, and we are well positioned to continue executing on our mission to transform the sleep disorder treatment landscape.”
Last week, the company dosed the first patient in the phase 3 trial in idiopathic hypersomnia, and a potential US Food and Drug Administration approval for the pediatric narcolepsy population is expected in September.
“We look forward to potentially extending Lumryz as a treatment option to both of these patient populations,” says Divis in a release.
Second Quarter and Recent Company Highlights
Lumryz Commercial Updates:
- Generated $41.5 million of net product revenue from sales of Lumryz in the second quarter of 2024.
- As of June 30, there were more than 1,900 patients on Lumryz compared to more than 1,400 as of March 31 and more than 900 as of Dec 31, 2023.
- From launch through June 30, approximately 3,800 patients had enrolled in Avadel’s RYZUP patient support services and more than 2,400 patients had initiated therapy.
Pipeline and Corporate Updates:
- Dosed the first patient in REVITALYZ, a phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of Lumryz in idiopathic hypersomnia. Enrollment is open to patients who are currently being treated with a twice-nightly oxybate and those not taking oxybates. The study is expected to enroll approximately 150 adults who are diagnosed with idiopathic hypersomnia and includes an open-label extension portion.
- Supplemental New Drug Application (sNDA) for Lumryz for the treatment of cataplexy or excessive daytime sleepiness in the pediatric narcolepsy population is under review with the FDA, with an assigned target action date of Sept 7.
- Pediatric patients currently represent approximately 5% of all oxybate-treated narcolepsy patients.
Overview of Second Quarter Financial Results
The company recognized $41.5 million in net product revenue for the second quarter 2024 compared to $1.5 million in the same period in 2023. Net product revenue consists of Lumryz product sales, which was launched in the US on June 5, 2023.
Gross profit for the second quarter 2024 was $38.7 million compared to $1.5 million in the same period in 2023.
