Third Quarter and Recent Company Highlights “We are fully committed to serving this important patient community and providing a much-needed and highly anticipated treatment option in the $3 billion plus once-at-bedtime oxybate market.” In this regard, we continue to execute our strategy to potentially accelerate the timeline to a final approval decision and shorten the timeline to a subsequent launch of LUMRYZ,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “With tentative approval in hand and approximately seven months or less from a final approval decision, we are in launch preparation mode to make LUMRYZ available to people living with narcolepsy as soon as possible following a final approval decision. 09, 2022 (GLOBE NEWSWIRE) - Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical 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, 2022. Management to host a conference call today at 8:00 a.m. Updated RESTORE data demonstrates 94% of switch patients prefer once-at-bedtime LUMRYZ dosing regimen presented new real-world data describing demographic characteristics and comorbidities of patients with narcolepsy All rights reserved.LUMRYZ™ granted tentative approval on July 18, confirming its safety profile and clinical efficacyįinal approval decision of LUMRYZ expected by June 2023 advancing strategy to potentially accelerate final approvalĬommercial launch planned for no later than Q3 2023 launch preparations underway The severity of narcolepsy reduces with the extension of natural course regardless of medication history.Ĭataplexy Narcolepsy type 1 Natural remission Segmentation Video-polysomnogram.Ĭopyright © 2019 Elsevier B.V. Resisting stage is necessary for every cataplexy and might reflect the compensation mechanism, while atonic stage may be omitted in some patients. However, medication history seems have no influence on either cataplexy duration or ESS score.įour-stage segmentation shows the dynamic process of the cataplectic attack, which is different from the traditional classification of complete or partial cataplexy. Both duration of cataplexy and ESS score are negatively correlated with disease course. The Epworth Sleepiness Scale score (ESS) has a positive correlation with the total duration of cataplexy. Resisting stage is predominant (56.4%) in cataplexy, while atonic stage is most related with the total duration of cataplexy. Four cataplectic stages (ie, triggering, resisting, atonic, and recovering) were identified according to clinical and electromyograms characteristics. Nine patients (43%) went through complete cataplectic attacks while the others experienced partial attacks. We observed 81 cataplectic episodes in 21 patients with diverse triggers, including humorous or exciting videos, tickling, recalling horrible memories and exercising. Correlations were analysed between cataplectic stages in pairs, and between cataplectic stages and other clinical features. Each cataplectic episode was segmented into four stages according to the v-PSG. The most serious cataplectic attack from each patient was analysed. We experimentally triggered patients with NT1 into cataplexy while under video-polysomnography (v-PSG) monitoring in the sleep lab. This study was conducted to clarify the clinical characteristics of cataplexy by staging, and to further analyse the correlations of clinical features and cataplectic stages in patients with narcolepsy type 1 (NT1). Cataplexy is a pathognomonic symptom of narcolepsy type 1.
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