Why Avadel Pharma Shares Are Gaining Today

  • Avadel Pharmaceuticals plc's AVDL shares are up Monday after the FDA granted final approval to Lumryz, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of 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. 
  • The FDA additionally granted Lumryz Orphan Drug Exclusivity.
  • The seven-year market exclusivity for Lumryz began on the date of FDA approval, May 1, 2023. 
  • In July 2022, the FDA tentatively approved Lumryz for cataplexy or EDS in adults with narcolepsy. 
  • Avadel submitted a minor amendment to the FDA on March 1, 2023, requesting the final approval of Lumryz. 
  • This minor amendment submission occurred shortly after delisting the REMS Patent from FDA's Orange Book by Jazz Pharmaceuticals Plc JAZZ in response to the unanimous 3-0 panel decision by the United States Court of Appeals for the Federal Circuit.
  • Lumryz has a boxed warning as a central nervous system depressant and for its potential for abuse and misuse.
  • Price Action: AVDL shares are up 11.35% at $11.67 on the last check Monday.
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