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Avadel Pharmaceuticals : Regulation FD Presentation - Form 8-K

Avadel Pharmaceuticals Announces Final FDA Approval of LUMRYZ™ for Extended-Release Oral Suspension as the First and Only Once-at-Bedtime Oxybate for Cataplexy or Excessive Daytime. | May 1, 2023

United statesCourtney turianoMichaelj thorpyGabriella greigGreg divisAvadel pharmaceuticals announces finalAvadel pharmaceuticalsAlbert einstein college of medicineUs food drug administrationSecurities exchangeCompany annual report on formWake disorders center at montefiore medicalExchange commissionStern investor relations incExtended release oral suspensionOnly once at bedtime oxybate

FDA Approves Once-at-bedtime Sodium Oxybate with Orphan Drug Exclusivity for Narcolepsy

This marks the first and only FDA-approved once-at-bedtime oxybate for individuals living with narcolepsy.

Greg divisMichael thorpyWake disorders center at montefiore medicalAvadel pharmaceuticals announces finalAlbert einstein college of medicineDrug administrationAvadel pharmaceuticalOrphan drug exclusivitySleep wake disorders centerMontefiore medical centerAlbert einstein collegeChief executive officerExtended release oral suspensionOnly once at bedtime oxybateExcessive daytime sleepiness

FDA Gives Final Approval to Sodium Oxybate for Cataplexy or Excessive Daytime Sleepiness in Adults With Narcolepsy

The final approval was based on efficacy and safety data from the phase 3 REST-ON study.

United statesGreg divisMichaelj thorpyAvadel pharmaceuticalsWake disorders center at montefiore medicalAlbert einstein college of medicineOrphan drugSleep wake disorders centerMontefiore medical centerAlbert einstein college

FDA Approves Once-Nightly Treatment for Narcolepsy

The FDA has granted final approval to Lumryz, a once-nightly sodium oxybate for the treatment of cataplexy or EDS in adults with narcolepsy.

Michaelj thorpyGreg divisWake disorders center at montefiore medicalAlbert einstein college of medicineDrug administrationAvadel pharmaceutical lumryzLumryz orphan drugOrphan drug exclusivitySleep wake disorders centerMontefiore medical centerAlbert einstein collegeRisk evaluationMitigation strategy

Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2022 Earnings Call Transcript

Operator: Greetings, and welcome to Avadel Pharmaceuticals Fourth Quarter and Full Year 2022 Earnings Call. It is now my pleasure to introduce Austin Murtagh with Stern Investor Relations. Thank you.

United statesGreg divisAustin murtaghChris howertonRichard kimTom mchughAdam everttsJennifer gudemanUs patent officeClinical affairsUnited states courtAvadel pharmaceuticalsFriendly companiesAmerican neurological associationAvadel pharmaceuticals plcAvadel pharmaceuticals fourth quarter

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