Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. Its main product is LUMRYZ is an extended-release formulation of sodium oxybate, which used in the treatment of cataplexy or EDS in adults with narcolepsy. The company was founded on July 21, 1990 and is headquartered in Dublin, Ireland.
Clinical Trials
0
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1990
No trial phase data available
No trial data available
No trial data available
No approval data available
- Mentari Therapeutics has named Greg Divis, former Avadel CEO, as its new chief executive officer effective July 20, 2026. - Divis brings over 30 years of industry experience, including leading Avadel through FDA approval and commercial launch of Lumryz and its $2.4 billion acquisition by Alkermes. - Mentari is advancing two migraine prevention candidates: MT-001, an anti-PACAP monoclonal antibody with regulatory filings expected mid-year 2026, and MT-002, an anti-PACAP/anti-CGRP bispecific antibody with filings planned for Q1 2027. - The company's pipeline targets the PACAP pathway independently of CGRP, aiming to address unmet needs for patients who do not achieve adequate symptom control with current therapies.
- More than three pharmaceutical companies are actively developing over four promising hypersomnia treatment candidates, signaling growing innovation in sleep disorder management. - Avadel Pharmaceuticals received FDA orphan drug designation in June 2025 for Lumryz, an extended-release sodium oxybate therapy for idiopathic hypersomnia. - Alkermes initiated a Phase II trial in April 2025 evaluating ALKS 2680, a selective orexin receptor modulator, in patients with idiopathic hypersomnia across global sites. - Axsome Therapeutics reported positive Phase III results in November 2024 for AXS-12 (reboxetine), demonstrating significant reductions in cataplexy episodes.
- Monopar Therapeutics appointed Susan Rodriguez as Chief Commercial and Strategy Officer to lead commercial strategy as the company prepares for a planned New Drug Application submission for ALXN1840 in the first half of 2026. - ALXN1840 represents the first major advancement in Wilson disease treatment in decades, with a novel mechanism of action as an albumin tripartite complex activator that differentiates it from current first-line therapies. - The company reported positive long-term efficacy and safety data from 255 patients with a median treatment duration of 2.63 years, demonstrating statistically significant improvement in copper balance. - Monopar strengthened its balance sheet with approximately $91.9 million raised through an underwritten public offering and expects current funds to support operations through at least December 31, 2027.
- Richard Pops will retire as Alkermes CEO on July 31, 2026, after 35 years of leadership that transformed the company from a 20-employee startup into a $1.5 billion revenue biopharmaceutical leader. - Blair Jackson, current Executive Vice President and Chief Operating Officer, will succeed Pops as CEO on August 1, 2026, while Pops continues as Chairman of the Board. - Under Pops' leadership, Alkermes evolved from a drug delivery specialist to a neuroscience-focused company with commercial products for mental health and addiction, plus a promising pipeline in sleep medicine including breakthrough-designated alixorexton. - The leadership transition comes as Alkermes expands into sleep medicine through the recent Avadel acquisition, adding FDA-approved Lumryz to its portfolio and positioning for growth in central disorders of hypersomnolence.
- Avadel Pharmaceuticals has completed patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZ (sodium oxybate) extended-release oral suspension for idiopathic hypersomnia treatment. - The double-blind, placebo-controlled trial will assess LUMRYZ's efficacy in reducing daytime sleepiness using the Epworth Sleepiness Scale as the primary endpoint at Week 14. - Results are expected in Q2 2026, potentially expanding LUMRYZ's approved indications beyond narcolepsy to address an underserved patient population of approximately 40,000 diagnosed IH patients in the United States.
- FDA veteran Richard Pazdur has accepted the director role at the Center for Drug Evaluation and Research (CDER), replacing George Tidmarsh who left amid conflict with biologics chief Vinay Prasad. - Internal FDA tensions have reached a breaking point, with sources warning of potential mass resignations if Prasad attempts to supersede Pazdur's authority at the drug evaluation center. - Pfizer emerged victorious in the high-stakes bidding war with Novo Nordisk for obesity biotech Metsera, while a separate acquisition battle has erupted between Lundbeck and Alkermes for sleep company Avadel Pharmaceuticals. - The FDA concluded one of the year's most controversial regulatory decisions by adding a black box warning to Sarepta's gene therapy Elevidys for serious liver toxicities and death risk.
- Avadel Pharmaceuticals and Jazz Pharmaceuticals reached a global settlement ending years of patent and antitrust litigation, with Jazz paying Avadel $90 million and granting perpetual patent licenses for Lumryz. - The agreement provides Avadel with a clear pathway to expand Lumryz into idiopathic hypersomnia treatment beginning March 1, 2028, subject to FDA approval. - Under the settlement terms, Avadel will pay Jazz ongoing royalties of 3.85% for narcolepsy sales through 2036, and 10% for future approved indications. - Lumryz, approved as the first once-nightly oxybate treatment for narcolepsy, demonstrated statistically significant improvements in excessive daytime sleepiness, clinical functioning, and cataplexy attacks in Phase 3 trials.
- Alkermes agreed to purchase Ireland-based Avadel Pharmaceuticals for $18.50 per share, with an additional $1.50 contingent payment if Lumryz receives FDA approval for idiopathic hypersomnia by 2028. - The acquisition provides Alkermes with Lumryz, an FDA-approved once-daily narcolepsy treatment serving over 3,100 patients and projected to generate $272-275 million in sales this year. - The deal positions Alkermes to compete in the sleep disorder market while preparing its own orexin receptor agonist alixorexton for phase 3 testing against Takeda's rival drug oveporexton.
- Avadel Pharmaceuticals presented 17 abstracts at World Sleep 2025, including new data from the REFRESH real-world study showing clinically meaningful improvements in narcolepsy symptoms with once-nightly LUMRYZ treatment. - The REFRESH study demonstrated that participants experienced improvements in excessive daytime sleepiness scores to within normal range and reduced severity of narcolepsy symptoms from moderate to mild. - LUMRYZ, the first and only once-at-bedtime sodium oxybate treatment, showed benefits for both patients switching from twice-nightly oxybates and those new to oxybate therapy. - Additional research revealed that patients with narcolepsy have significantly higher rates of sleep, pain, and psychiatric comorbidities compared to matched controls, highlighting the broader disease burden.
- Avadel Pharmaceuticals has secured exclusive global licensing rights to valiloxybate from XWPharma for $20 million upfront, with potential milestone payments exceeding $205 million. - Valiloxybate represents the first salt-free, artificial sweetener-free, once-at-bedtime oxybate therapy designed for treating narcolepsy and idiopathic hypersomnia. - The company plans to initiate pharmacokinetic studies in Q4 2025, followed by pivotal trials in H2 2026, leveraging a streamlined bioequivalence pathway. - This acquisition strengthens Avadel's position in the expanding sleep medicine market, valued at $5.3 billion in 2024 and projected to reach $8.6 billion by 2033.
