Avadel Pharmaceuticals plc (Nasdaq: AVDL) has announced a corporate update and financial results for the third quarter of 2024, highlighting the commercial success and clinical advancements of LUMRYZ™ (sodium oxybate) for extended-release oral suspension.
Financial Performance and Commercial Growth
Avadel reported $50.0 million in net product revenue from LUMRYZ sales for the third quarter of 2024, a significant increase from $7.0 million in the same period last year. As of September 30, 2024, 2,300 patients were on LUMRYZ, including 700 new patients who initiated therapy during the quarter. Notably, the fastest-growing patient segment consists of those new to oxybate treatments.
Expanded FDA Approval and Orphan Drug Exclusivity
On October 16, 2024, the U.S. Food and Drug Administration (FDA) approved LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged 7 years and older with narcolepsy. This approval extends LUMRYZ's availability to a younger patient population and grants Orphan Drug Exclusivity (ODE) through October 16, 2031.
Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals, stated, "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...significantly alleviating the burden on patients and their caregivers of waking up in the middle of the night to administer treatment."
Legal Victory and Clinical Superiority
The U.S. District Court for the District of Columbia ruled in favor of the FDA in a suit brought by Jazz Pharmaceuticals Inc., upholding the approval of LUMRYZ. The court affirmed the FDA’s determination that LUMRYZ, dosed once at bedtime, demonstrates clinical superiority to twice-nightly oxybate products.
Ongoing Clinical Development
Patient enrollment is ongoing in the REVITALYZ pivotal study, a Phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study. This trial is designed to evaluate the efficacy and safety of LUMRYZ in patients with idiopathic hypersomnia (IH).
Additional Data and Analyses
During the quarter, Avadel announced the publication of several key findings:
- A post-hoc analysis showed consistent efficacy in participants currently taking alerting agents, highlighting LUMRYZ's benefit in augmenting response, with 37% responding positively on LUMRYZ monotherapy.
- Data from the RESTORE open-label study, involving the largest cohort of switch patients, revealed that 94% preferred the once-nightly dosing regimen, and 93% would recommend LUMRYZ to others with narcolepsy.
- Another post-hoc analysis demonstrated weight loss associated with LUMRYZ compared to placebo, with shifts from obese to overweight and overweight to normal BMI categories.
Financial Overview
Gross profit for the third quarter of 2024 was $43.9 million, compared to $6.9 million in the same period in 2023. Total operating expenses were $44.2 million, including $6.4 million of non-cash charges. The operating loss was $0.3 million, a significant improvement from the $35.1 million loss in the same period last year. Cash, cash equivalents, and marketable securities totaled $65.8 million as of September 30, 2024.
Avadel is focused on advancing LUMRYZ and expanding its reach to improve the lives of patients with narcolepsy and idiopathic hypersomnia. The company intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
