Avadel Pharmaceuticals Sees Robust Uptake For Its Newly Approved Sleep Disorder Drug

Avadel Pharmaceuticals plc AVDL recognized $7.0 million in net product revenue for Q3. Net product revenue consists of Lumryz product sales, launched in the U.S. in June. Analysts estimated revenues of $5.09 million.

In May, the FDA granted final approval to Lumryz, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Narcolepsy is a chronic neurological disorder that affects the brain's ability to control the sleep-wake cycle.

With final approval, Lumryz becomes the first and only FDA-approved once-at-bedtime oxybate for narcolepsy. 

Avadel Pharmaceuticals reported a Q3 EPS loss of $(0.41) versus $(0.33) a year ago.

The company reported that over 1,000 patients enrolled in Avadel's RYZUP patient support services:

More than 400 patients initiated therapy with LUMRYZ during Q3.

Approximately 600 patients remained in the RYZUP process, going through the benefits investigation or pending their first shipment.

RYZUP enrollments and patients currently being treated with Lumryz include the majority switch patients from first-generation oxybates, followed by patients who previously tried and discontinued a first-generation oxybate, and patients who are new to oxybates.

Avadel also said that Lumryz to be added to the preferred position for CVS commercial formularies effective January 1, 2024

The company also submitted a supplemental U.S. marketing application for Lumryz in the pediatric narcolepsy population.

Price Action: AVDL shares are up 11.6% at $11.58 on the last check Wednesday.