Federal court upholds FDA approval of Jazz's sleep drug rival

The US District Court for Washington, DC, has rejected Jazz Pharmaceuticals' bid to nullify the FDA's approval of a competing sleep medication developed by Avadel Pharmaceuticals. Avadel's drug, Lumryz, like Jazz's Xywav, utilizes the active ingredient oxybate to treat sleep disorders, but Lumryz offers the advantage of being taken once nightly instead of twice.

In July 2020, the FDA approved Xywav and granted Jazz Pharmaceuticals a seven-year marketing exclusivity period, preventing other drugs with the same active ingredient from entering the market during that time. Although both Xywav and Lumryz contain oxybate and address the same condition, the FDA found Lumryz's once-nightly dosage to be "clinically superior" to Xywav's twice-daily regimen.

This determination of clinical superiority led the FDA to conclude that the two medications are not identical, allowing both to be approved under the Orphan Drug Act. This act provides seven years of exclusivity for drugs that treat rare diseases affecting fewer than 200,000 patients in the United States.

The court's opinion, issued on Wednesday, emphasized that the FDA's decision was reasonable. It noted that since the primary goal of oxybate therapy is to improve sleep consolidation, a medication that only requires a single nightly dose offers a significant improvement in patient care compared to one that necessitates waking up for a second dose.

Greg Divis, CEO of Avadel Pharmaceuticals, expressed satisfaction with the court's ruling. He highlighted that Lumryz will remain available to patients with narcolepsy and will enjoy its own period of market exclusivity under the Orphan Drug Act.

In addition to this court decision, the FDA recently extended its approval of Lumryz to include pediatric patients aged seven years and older who suffer from narcolepsy. This approval, granted on October 16, is expected to broaden the drug's market reach.

Lumryz has already shown promising commercial performance. Last year, it generated approximately $28 million in sales. Market analysts at Leerink Partners have projected that Lumryz could capture over 20% of the narcolepsy treatment market.

This ruling represents a significant development for both Jazz Pharmaceuticals and Avadel Pharmaceuticals. While Jazz sought to protect its market position by challenging the FDA's approval of a competing drug, the court's decision ultimately supports the availability of more treatment options for patients. For Avadel, the ruling solidifies Lumryz's place in the market and underscores the value of its once-nightly dosing regimen, which is seen as a major advantage for patients dealing with sleep disorders.