Avadel Pharmaceuticals Announces Favorable Ruling Regarding Sleep Disorder Drug Patent

Benzinga
2022-11-21
  • Avadel Pharmaceuticals plc (NASDAQ: AVDL) announced that the United States District Court for the District of Delaware ordered Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) to delist U.S. Patent No. 8731963 (the REMS Patent) from the FDA Orange Book. 
  • With this decision, Avadel seeks to accelerate the FDA's final approval for Lumryz, a once-at-bedtime formulation of sodium oxybate for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
  • In July, Lumryz received tentative approval from the FDA, with potential final approval pending the disposition of the REMS Patent. 
  • Price Action: Avadel Cuts Workforce, Optimizes Cost Structure.
  • In October, a Markman hearing was held in which Avadel renewed its request for expedited consideration of its pending motion to have the REMS Patent delisted from the FDA's Orange Book. 
  • The Delaware Court granted that request and held a hearing on that motion. 
  • Avadel is currently evaluating the long-term safety and tolerability of Lumryz in the open-label RESTORE clinical study. 
  • Price Action: AVDL shares are 0.12% lower at $8.01 during premarket trading on Monday.

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