Core Viewpoint - Avadel Pharmaceuticals has completed patient enrollment in the REVITALYZ Phase 3 trial for LUMRYZ, an extended-release oral suspension of sodium oxybate, aimed at treating idiopathic hypersomnia (IH) [2][5]. Group 1: Trial Details - REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal trial assessing the efficacy and safety of LUMRYZ administered as a once-at-bedtime dose for IH patients [3]. - The primary objective is to demonstrate a reduction in daytime sleepiness, measured by the change in total score on the Epworth Sleepiness Scale (ESS) at Week 14 [4]. - Secondary endpoints will evaluate additional efficacy parameters, including patient and clinician impressions, severity of IH, and functional outcomes of sleep [4]. Group 2: Market Need and Potential - Idiopathic hypersomnia is a serious sleep disorder affecting approximately 40,000 diagnosed patients in the U.S., characterized by extreme difficulty waking up and persistent daytime sleepiness [6]. - The approval of LUMRYZ could provide a valuable treatment option for IH patients, as current treatments are limited [4][5]. Group 3: Background on LUMRYZ - LUMRYZ was approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy [7]. - The drug received Orphan Drug Designation for IH in June 2025, indicating its potential clinical superiority over existing treatments [9][10]. - LUMRYZ's once-nightly dosing regimen is designed to improve patient care by avoiding nocturnal arousal for a second dose [9].

Acquisition Rationale - The acquisition augments revenue growth and diversifies Alkermes' commercial portfolio with LUMRYZ[22] - It accelerates Alkermes' entry into the sleep medicine market and provides a foundation for alixorexton's potential launch[22] - The acquisition is expected to be immediately accretive and enhance profitability upon closing[22] - The combined organization will be positioned to accelerate innovation in sleep and neurological disorder treatments[22] - The acquisition drives operational efficiencies and synergies as Alkermes prepares for alixorexton's potential launch[22] Avadel Pharmaceuticals Highlights - Avadel successfully developed and obtained regulatory approval for LUMRYZ for narcolepsy[23] - Since launch, LUMRYZ has generated over $300 million in net revenues (as of June 30, 2025)[23] - Avadel achieved profitability and positive cash flow in Q2 2025[23] - Approximately 3,100 patients are on LUMRYZ therapy (as of June 30, 2025)[26] - The company estimates there are over 50,000 oxybate-eligible patients with narcolepsy in the U S[26] - LUMRYZ is expected to generate net revenues in the range of $265 - $275 million in 2025[26] Transaction Terms - Alkermes will acquire Avadel in an all-cash transaction for $18 50 per share[33] - A Contingent Value Right (CVR) offers a potential additional payment of $1 50 per share tied to FDA approval of LUMRYZ in idiopathic hypersomnia by the end of 2028[33] - The total consideration is up to $20 00 per share, or a transaction value of up to $2 1 billion[33]