Why Avadel Pharma (AVDL) Shares Are Gaining Today - Avadel Pharmaceuticals (NASDAQ:AVDL)

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.

Why Avadel Pharma Shares Are Gaining Today