Summary: Avadel Pharmaceuticals reported strong third-quarter results, generating $50 million in revenue from its narcolepsy treatment Lumryz. The company recently received FDA approval to expand Lumryz use to pediatric patients, secured a favorable court ruling affirming the treatment’s clinical superiority over twice-nightly oxybate products, and continued progress in its Phase 3 trial for idiopathic hypersomnia. Lumryz has seen growing patient demand, especially among those new to oxybate therapy.
Key Takeaways:
- Strong Revenue Growth: Avadel generated $50 million in Q3 revenue driven by increased demand for Lumryz, with 2,300 patients on the treatment as of September.
- Regulatory and Legal Wins: Lumryz received FDA approval for treating narcolepsy in patients aged 7 and older and successfully defended its approval in a lawsuit, securing Orphan Drug Exclusivity through 2031.
- Expanding Clinical Research: The company is actively enrolling patients in a Phase 3 trial to evaluate Lumryz’s efficacy for idiopathic hypersomnia, with ongoing studies highlighting its benefits for narcolepsy patients.
Avadel Pharmaceuticals reported $50 million in third-quarter revenue from its narcolepsy treatment Lumryz, which recently gained US Food and Drug Administration (FDA) approval for use in pediatric patients and saw its clinical superiority upheld in court.
“Over a year ago, we set out on our mission to transform the lives of those living with narcolepsy, including expanding the oxybate market through the introduction of Lumryz. This quarter, we are proud to see that expansion come to fruition and continue to be encouraged by patient uptake and quarter-over-quarter growth of Lumryz,” says Greg Divis, chief executive officer of Avadel Pharmaceuticals, in a release.
He continues, “In parallel to our launch in adults with narcolepsy, we are expanding into additional patient populations, starting with the recent FDA approval of Lumryz for the treatment of cataplexy or EDS (excessive daytime sleepiness) in patients 7 years and older with narcolepsy, significantly alleviating the burden on patients and their caregivers of waking up in the middle of the night to administer treatment.
“We are also pleased with the recent court ruling affirming FDA’s determination that Lumryz, dosed once at bedtime, demonstrates clinical superiority to twice-nightly oxybates, which mitigates an important legal and business risk for the company.
Third-quarter and recent company highlights include:
Lumryz commercial updates:
- Generated $50 million of net product revenue from sales of Lumryz in the third quarter of 2024.
- As of Sept 30, there were 2,300 patients on Lumryz compared to 1,900 patients on Lumryz on June 30.
- In the third quarter, generated consistent patient demand for Lumryz with 700 patients initiating therapy.
- Observed continuing growth in demand from patients who are new to oxybate – these patients represent the fastest-growing patient segment for Lumryz.
Corporate and pipeline updates:
- On Oct 30, the US District Court for the District of Columbia ruled in favor of the FDA in a suit brought by Jazz Pharmaceuticals Inc under the Administrative Procedure Act regarding the FDA’s approval of Lumryz.
- With this ruling, the approval of Lumryz is upheld based on the FDA’s determination that Lumryz is clinically superior to Jazz’s twice-nightly oxybate products.
- On Oct 16, the FDA approved Lumryz for the treatment of cataplexy or EDS in patients 7 years or older with narcolepsy.
- Lumryz was granted Orphan Drug Exclusivity for this patient population through Oct 16, 2031.
- Patient enrollment is ongoing in the REVITALYZ pivotal study, a phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of Lumryz in idiopathic hypersomnia (IH).
- During the quarter ended Sept 30, announced publication of results of:
- A post-hoc analysis showing consistent efficacy in participants currently taking alerting agents, highlighting the benefit of Lumryz to augment response, as well as the 37% who responded positively based upon Lumryz monotherapy.
- Data from the RESTORE open-label study, based upon the largest cohort of switch patients, in which 94% preferred the once-nightly dosing regimen and 93% who would recommend Lumryz to a friend or family member with narcolepsy.
- A post-hoc analysis demonstrating weight loss associated with Lumryz compared to placebo, and shifting from obese category into overweight and overweight into normal BMI categories.
“With our phase 3 pivotal trial in IH ongoing, our continued execution of the Lumryz launch including our expansion of Lumryz into pediatric narcolepsy, we are closing in our business objectives of being a leader in the sleep field and fulfilling the promise of Lumryz for all stakeholders,” says Divis in the release.
Photo caption: Lumryz
File photo/Avadel Pharmaceuticals
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