Avadel Pharmaceuticals plc provided a second-quarter corporate update detailing the progress following Lumryz’s approval by the US Food and Drug Administration (FDA) during the period and upcoming milestones, including seeking an expanded indication for Lumryz.

The FDA approved Lumryz on May 1 as the first and only once-at-bedtime oxybate therapy for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. 

The FDA also found Lumryz to be clinically superior to currently marketed twice-nightly oxybate products and granted Lumryz seven years of Orphan Drug Exclusivity. In particular, FDA found that Lumryz makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that does not disrupt or fragment sleep, whereas twice-nightly oxybates necessitate a nocturnal awakening to take a second dose, which disrupts sleep architecture in patients with known sleep disorders. 

The drug became commercially available in June, and the company reports “significant” early progress on payor coverage, prescriber certifications, and patient enrollments. 

“This past quarter has been transformative for our organization, underscored by US FDA approval of Lumryz…and subsequent US commercial launch. We are pleased to have completed our first patient enrollments and commercial sales of Lumryz within weeks of receiving FDA approval,” says Greg Divis, CEO of Avadel Pharmaceuticals, in a release. 

Divis continues, “We are also encouraged with the high level of interest from sleep specialists and the initial demand observed across all patient segments. We believe the promising initial launch results we are seeing, combined with our strong commercial capabilities and robust market research, positions us to command a meaningful share of the estimated greater than 50,000 patients who are eligible for Lumryz.”

In addition to continuing commercialization efforts, Avadel aims to expand the potential of Lumryz with a supplemental New Drug Application filing planned in the second half of 2023 for Lumryz in the pediatric narcolepsy population for the treatment of cataplexy or excessive daytime sleepiness.

During the first two months of the US commercial launch of Lumryz:

  • Avadel initiated sales of Lumryz to the specialty pharmacies in the company’s distribution network.
  • Greater than 1,000 health care providers have completed the Lumryz REMS certification process, which enables them to prescribe Lumryz to patients.
  • Greater than 400 patients have enrolled in Avadel’s RYZUP patient support services to begin the process of getting Lumryz prescriptions fulfilled and shipped.
  • Secured Express Scripts coverage on the National Preferred Formulary, effective July 1.

Clinical updates:

  • The discrete choice experiment indicated that among sleep clinicians, the frequency of oxybate treatment dosing was the most important driver for overall product choice, improved patient quality of life, and reduced patient anxiety and stress.
  • Once-nightly dosing was preferred over twice-nightly dosing, and these data underscore the unmet need for an oxybate treatment that does not require middle-of-the-night dosing.
  • In May, announced new data supporting the clinical profile for Lumryz at SLEEP 2023, the 37th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society.
  • With 12 posters presented, including six oral presentations, the company highlighted its leadership in the narcolepsy space, and the data adds to the growing body of evidence demonstrating positive clinical benefit and patient preference of once-at-bedtime Lumryz.
  • In June, for the third year in a row, Avadel was the lead sponsor of the Academy of Sleep Medicine Foundation’s 2023 Young Investigators Research Forum.
  • In May, post-hoc analysis of phase 3 REST-ON trial of Lumryz (sodium oxybate) was published in SLEEP. By stratifying narcolepsy type 1 and narcolepsy type 2 at baseline in the study design, the REST-ON data provides insight that Lumryz improves excessive daytime sleepiness and disrupted nighttime sleep in either narcolepsy type.