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FDA Approves Once-Nightly Lumryz for Patients With Narcolepsy

The FDA has granted final approval to Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.

Michaelj thorpyWake disorders center at montefiore medicalAlbert einstein college of medicineDrug administrationWakefulness testClinical global impressionSymptom dailySleep wake disorders centerMontefiore medical centerAlbert einstein college

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 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 Lumryz for Patients With Narcolepsy

The FDA has granted final approval to Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.

Michaelj thorpyWake disorders center at montefiore medicalDrug administrationAlbert einstein college of medicineWakefulness testClinical global impressionSymptom dailySleep 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

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