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Avadel Pharmaceuticals Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2021 Financial Results August 9 , 2021 • Commercial and launch preparations on track to support potential U.S. FDA approval of FT218 for the treatment of excessive daytime sleepiness and cataplexy in adults suffering from narcolepsy • Presentation of post hoc analyses from pivotal REST - ON clinical trial at SLEEP 2021 further support positive primary and secondary endpoint data for all evaluated doses of FT218 , beginning as early as week three of treatment • Expansion of leadership team with addition of established biopharma industry leaders • Management to host a conference call today at 8:30 a.m. ET -- DUBLIN , Ireland , Aug. 09 , 2021 ( GLOBE NEWSWIRE ) Avadel Pharmaceuticals plc ( Nasdaq : AVDL ) , a company focused on developing FT218 , an investigational , once - nightly formulation of sodium oxybate for treating excessive daytime sleepiness ( EDS ) and cataplexy in adults with narcolepsy , today provided a corporate update and announced its financial results for the second quarter ended June 30 , 2021 . " This quarter , we made significant progress advancing FT218 , which we believe holds tremendous potential to transform the treatment landscape for patients as a once - at - bedtime option for managing EDS and cataplexy in adult patients with narcolepsy . The data presented at SLEEP 2021 demonstrates the additional benefit of consolidating sleep , which we believe holds great promise as many people with narcolepsy also suffer from fragmented sleep , " said Greg Divis , Chief Executive Officer of Avadel . " As we enter the final stages of NDA review and approach our October PDUFA date , we remain confident in the strength of our regulatory filing strategy . In parallel , our commercial and launch preparations are on track , including the addition of key hires to our leadership team , and we look forward to providing more detail on our commercial strategy following potential approval of FT218 . " Second Quarter and Recent Company Highlights • Progressed preparations and launch readiness activities for the potential commercialization of FT218 as the first and only once - at - bedtime option for managing EDS and cataplexy in narcolepsy • New Drug Application ( NDA ) for FT218 was accepted for filing by the U.S. Food and Drug Administration ( FDA ) in February 2021 , and was assigned a Prescription Drug User Fee Act ( PDUFA ) target action date of October 15 , 2021 • Conducting scientific and medical community engagement and education , as well as payor clinical presentations • Presented new clinical post - hoc analyses from the pivotal Phase 3 REST - ON clinical study at SLEEP 2021 further supporting clinical benefit of all evaluated doses of FT218 , beginning as early as week three of treatment o Data demonstrated improvement in EDS for both narcolepsy subtypes with and without stimulant use as well as decreases in weight and body mass index • Expanded leadership team with addition of established biopharma industry leaders to support anticipated regulatory approval and commercialization of FT218 • • Appointed Jeff Cruikshank as Vice President , Sales ; Denise Strauss as Vice President , Marketing and New Product Strategy ; and Angela Woods as Vice President , People and Culture Progressed the RESTORE open - label extension / switch study of FT218 designed to generate long - term safety , tolerability , and efficacy data , as well as data on switching from twice - nightly oxybates and patient preference Avadel plans to present data from RESTORE study on patient preference to once - nightly or twice - nightly dosing regimens , as well as nocturnal experiences when using twice - nightly sodium , at future medical congresses . Overview of Second Quarter Results As a result of the sale of the sterile injectable products to Exela Sterile Medicines LLC on June 30 , 2020 , the Company did not report any revenue for the quarter ended June 30 , 2021 , compared to $ 10.1 million for the same period in 2020 . R & D expenses were $ 6.8 million in the quarter ended June 30 , 2021 , compared to $ 4.1 million for the same period in 2020. The increase on a year - over - year basis was primarily attributed to increased costs associated with pre - NDA approval activities , primarily the purchase of raw materials , in preparation for product launch , if FT218 is approved .