Following a recent favorable court decision, Avadel Pharmaceuticals plc (NASDAQ: AVDL) stock is enjoying a notable increase this morning, rising 17.89% to $15.22 as of the last check. The U.S. District Court for the District of Columbia ruled in favor of the FDA, thus dismissing Jazz Pharmaceuticals’ complaint under the Administrative Procedure Act.
Avadel’s LUMRYZ, the first single-dose oxybate medication for narcoleptics who suffer from cataplexy or severe daytime sleepiness, was challenged in court after the FDA approved it. This decision upholds the FDA’s stance that LUMRYZ is clinically superior than Jazz’s twice-nightly oxybate medications, ensuring the continuation of LUMRYZ’s authorized status.
Legal Background: Jazz Pharmaceuticals’ Challenge
After LUMRYZ received a seven-year Orphan Drug Exclusivity (ODE) grant and final FDA clearance in May 2023, Jazz Pharmaceuticals sued the FDA, claiming the approval violated the Orphan Drug Act. Avadel CNS Pharmaceuticals, LLC (“Avadel CNS”) entered the action in support of the FDA, arguing that LUMRYZ’s approval should be maintained due to its clinical superiority in minimizing the need for patients to get up throughout the night to take a second dosage.
FDA’s Findings on Clinical Superiority
In its approval, the FDA emphasized LUMRYZ’s ability to provide a once-nightly dosing regimen, a notable advancement over the twice-nightly requirement of existing oxybate treatments. This shift reduces nocturnal awakenings, offering patients with narcolepsy an improved treatment option that minimizes sleep disturbances.
Recently, in October 2024, the FDA extended this exclusivity for pediatric patients aged seven and older, recognizing that LUMRYZ’s single-dose schedule significantly contributes to patient care by supporting uninterrupted sleep, unlike twice-nightly regimens.
Impact of the Ruling on Avadel and the Narcolepsy Community
This court decision affirms LUMRYZ’s unique role in narcolepsy treatment and reinforces its market position, permitting Avadel to move forward with its commercial rollout. The ruling also highlights the FDA’s recognition of LUMRYZ’s dosing schedule as a significant contribution to patient care within the narcolepsy community.
With Orphan Drug Exclusivity intact, Avadel (AVDL) is positioned to expand LUMRYZ’s presence, offering a clinically advanced solution for those managing cataplexy and excessive daytime sleepiness.
