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Avadel Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2021 Financial Results November 8 , 2021 • FDA review of NDA for FT218 ongoing ; commercial and launch preparations progressing • Presentation of new data from pivotal REST - ON clinical trial at CHEST 2021 demonstrating that treatment with FT218 causes meaningful improvement in cataplexy attacks and measurements of EDS with a dosing regimen preferred by patients • Management to host a conference call today at 8:30 a.m. ET DUBLIN , Ireland , Nov. 08 , 2021 ( GLOBE NEWSWIRE ) -- Avadel Pharmaceuticals plc ( Nasdaq : AVDL ) , a company focused on transforming medicines to transform lives , today provided a corporate update and announced its financial results for the third quarter ended September 30 , 2021 . " The need for patients living with the chronic , debilitating condition of narcolepsy to have a single bedtime dose of sodium oxybate is clear . We are confident in the strength of our data and our regulatory filing strategy for FT218 , as the FDA continues their review of our NDA . Importantly , there are no outstanding requests from the FDA at this time , and questions previously received have been addressed . We remain committed to patients and sleep specialists , demonstrated by the significant advances we made during 2021 to support a successful launch of FT218 , if approved , " said Greg Divis , Chief Executive Officer of Avadel . " This quarter , we published the primary REST - ON results in the SLEEP journal and continued to externalize the robust dataset supporting the potential of FT218 in various scientific congresses . Additionally , payor discussions continue to advance , and we are growing our commercial team , all with the vision of disrupting the narcolepsy market and fulfilling our promise to the narcolepsy community by bring FT218 to patients . " Third Quarter and Recent Company Highlights • In October 2021 , the U.S. Food and Drug Administration ( FDA ) informed the company that the review of its New Drug Application ( NDA ) for FT218 was ongoing beyond its previously assigned target action date . • Continued preparations and launch readiness activities for the potential commercialization of FT218 as the first and only once - at - bedtime option for managing excessive daytime sleepiness ( EDS ) and cataplexy in narcolepsy • Multiple presentations and publications in peer - reviewed forums of data from the pivotal Phase 3 REST - ON study of FT218 throughout the quarter , including : • o Published the previously announced primary results in SLEEP , the journal of the Sleep Research Society o Presented new data at the American College of Chest Physicians ( CHEST ) annual meeting supporting the clinical benefit of once - at - bedtime FT218 and patient preference for once - nightly dosing : ■ New post - hoc responder analyses demonstrated FT218 treatment was associated with statistically significant improvements compared to placebo on the number of weekly cataplexy episodes and statistically significant improvements compared to placebo on mean sleep latency ■ Discrete choice experiment demonstrated that the strongest driver of patient preference for sodium oxybate was dosing frequency with once - nightly dosing preferred • Presented encore posters featuring post hoc analyses from the REST - ON study at the meeting of the American Neurological Association 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 o 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 Third Quarter Results R & D expenses were $ 4.4 million in the quarter ended September 30 , 2021 , compared to $ 5.6 million for the same period in 2020. The decrease on a period - over - period basis was primarily attributed to lower clinical studies expenses and purchases of active pharmaceutical ingredients used in the research and development of FT218 during the current period . SG & A expenses were $ 21.3 million in the quarter ended September 30 , 2021 , compared to $ 8.4 million for the same period in 2020. The period- over - period increase is the result of a number of factors including commercial launch planning costs related to FT218 , higher legal and professional fees , and higher compensation costs associated with higher headcount , primarily in the areas of commercial and medical affairs . Income tax benefit was $ 5.1 million in the quarter ended September 30 , 2021 , compared to income tax benefit of $ 5.0 million for the same period in 2020 .