Patient usage of Lumryz in increased 70% in Q1, while Avadel plans to expand into pediatric treatment and launch a phase 3 trial in idiopathic hypersomnia.

Summary:

Avadel Pharmaceuticals reported a significant increase in Lumryz usage for narcolepsy, with over 1,700 patients initiating therapy—a 70% rise since December. The company is looking to expand Lumryz’s indications into pediatric treatment and launch a phase 3 trial for idiopathic hypersomnia later this year. Avadel’s patient support program also saw growth, with more than 2,800 enrollments. Lumryz, approved in May 2023, is the first once-at-bedtime treatment for cataplexy and excessive daytime sleepiness in adults.

Key Takeaways:

As of March 31, over 1,700 patients have initiated therapy with Lumryz, marking an increase of more than 70% since Dec 31.
The US Food and Drug Administration has accepted the Supplemental New Drug Application for Lumryz for the treatment of cataplexy or excessive daytime sleepiness in the pediatric narcolepsy population, with a target action date set for Sept 7.
Avadel is on track to enroll the first patient in a phase 3 pivotal trial for the use of Lumryz to treat idiopathic hypersomnia in the second half of 2024.

Avadel Pharmaceuticals plc, which commercially launched Lumryz for narcolepsy a year ago, provided a first-quarter corporate update, reporting a substantial increase in the number of patients using the therapy.

The company also discussed exploring additional applications for Lumryz, including a potential expansion into pediatric treatment and a phase 3 trial for idiopathic hypersomnia scheduled for later this year.

“We are pleased to report another strong quarter of launch performance from Lumryz as we continue to serve the narcolepsy patient community. The continued positive feedback we hear daily from patients, prescribers, and caregivers builds on the strong commercial foundation we established early into the launch,” says Greg Divis, chief executive officer of Avadel Pharmaceuticals, in a release. “Over the course of 2024, we will be laser-focused on the continued market growth of Lumryz for the treatment of narcolepsy as well as potentially expanding to the pediatric population and initiating our phase 3 pivotal trial in idiopathic hypersomnia in the second half of the year.”

First Quarter and Recent Company Highlights

Lumryz commercial updates:

Greater than 1,700 patients initiated therapy as of March 31, representing an increase of greater than 70% from Dec 31.
- More than 2,800 patients enrolled in Avadel’s RYZUP patient support services, an increase of approximately 50% since Dec 31.
- The majority of RYZUP enrollments and patients currently being treated with Lumryz are patients who switched from first generation oxybates, with the balance made up of patients who previously tried and discontinued a first generation oxybate and patients who are new to oxybate treatment.

Pipeline updates:

The US Food and Drug Administration (FDA) accepted the Supplemental New Drug Application for Lumryz for treatment of cataplexy or excessive daytime sleepiness in the pediatric narcolepsy population. The FDA has assigned a target action date of Sept 7.
- With potential approval in the pediatric population, Lumryz could alleviate the burden placed on families and caregivers of children with narcolepsy who are responsible for waking up in the middle of the night to administer a second dose, according to a release from Avadel Pharmaceuticals.
- Pediatric patients currently represent approximately 5% of all oxybate-treated narcolepsy patients.
On track to enroll the first patient in a phase 3 pivotal trial for the use of Lumryz to treat idiopathic hypersomnia in the second half of 2024.

Lumryz is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy.  