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Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a specialty pharmaceutical company headquartered in Dublin, Ireland, with operations in St. Louis, Missouri, and Lyon, France. The company focuses on developing, identifying, and commercializing differentiated pharmaceutical products designed to be safe, effective, and easy to administer, thereby improving patient adherence and outcomes. Avadel's products primarily target the urology, central nervous system (CNS) / sleep, and hospital markets.
One of Avadel's flagship products is LUMRYZ™, an extended-release formulation of sodium oxybate, approved by the U.S. Food & Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. LUMRYZ is notable for its once-at-bedtime dosing, which eliminates the need for a middle-of-the-night dose, making it more convenient for patients.
The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity, recognizing it as a major contribution to patient care over existing therapies. The approval was supported by results from the REST-ON trial, a Phase 3 study that demonstrated significant improvements in EDS, the Clinician Global Impression of Improvement (CGI-I), and reduced the frequency of cataplexy attacks.
Avadel recently announced its financial results for the third quarter ended September 30, 2023, reporting $7.0 million in net product revenue from LUMRYZ sales. The company has seen robust demand and positive feedback from the narcolepsy community, healthcare providers, and payers. Notably, CVS Health has moved LUMRYZ to preferred status starting January 1, 2024. Avadel also filed a supplemental NDA to extend LUMRYZ's indication to pediatric patients with narcolepsy, further expanding its market reach.
Financially, Avadel reported a net loss of $36.3 million for the quarter, driven by higher selling, general, and administrative expenses related to the LUMRYZ launch. Despite these challenges, the company maintains a strong cash position of $153.2 million as of September 30, 2023.
Looking ahead, Avadel plans to issue its Annual Report on Form 10-K for the year ended December 31, 2023, on February 29, 2024. The company continues to focus on expanding its product pipeline, including initiating a Phase 3 trial for idiopathic hypersomnia and optimizing commercial execution for LUMRYZ.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced FDA approval of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older. LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for this condition, granted Orphan Drug Exclusivity for pediatric narcolepsy patients through October 16, 2031.
This approval expands LUMRYZ's use to the pediatric population, offering a single bedtime dose option. Narcolepsy affects about 1 in 2,000 people in the US, with 5% under 18. LUMRYZ was first approved for adult narcolepsy patients on May 1, 2023. The drug carries a boxed warning as a CNS depressant with potential for abuse and is available only through a restricted REMS program.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the publication of a post-hoc analysis from their Phase 3 REST-ON clinical trial for LUMRYZ (sodium oxybate) in treating narcolepsy. The study, published in Sleep Medicine, showed that LUMRYZ significantly improved wakefulness, overall condition, weekly cataplexy episodes, and excessive daytime sleepiness compared to placebo, regardless of concomitant use of alerting agents.
The analysis involved 119 participants (63%) taking alerting agents and 71 (37%) not taking them. Significant improvements were observed with LUMRYZ at all doses versus placebo for Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) rating, and weekly cataplexy episodes (p<0.05). The Epworth Sleepiness Scale (ESS) also showed significant improvements in both groups.
These findings highlight that alerting agents alone may be insufficient for treating excessive daytime sleepiness in narcolepsy patients, and LUMRYZ could be an effective treatment option, either as monotherapy or in combination with alerting agents.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced the publication of final data from the RESTORE study, highlighting the advantages of LUMRYZ, their once-nightly oxybate treatment for narcolepsy, over twice-nightly alternatives. Key findings include:
- 94% of participants preferred LUMRYZ's once-nightly regimen
- 91% reported better sleep through the night with LUMRYZ
- 93% would recommend LUMRYZ to others with narcolepsy
- 79% were very satisfied with LUMRYZ compared to previous treatments
The study also revealed challenges with twice-nightly oxybates, including missed doses, grogginess, and the need for assistance in taking the second dose. LUMRYZ, approved by the FDA in 2023, addresses these issues as the first and only once-nightly oxybate treatment for narcolepsy.
Avadel Pharmaceuticals (Nasdaq: AVDL), a biopharmaceutical company, has announced its participation in three upcoming investor conferences in September 2024:
- 2024 Wells Fargo Healthcare Conference: Fireside chat on September 4 at 3:45 p.m. ET
- Morgan Stanley 22nd Annual Global Healthcare Conference: Fireside chat on September 6 at 10:00 a.m. ET
- H.C. Wainwright 25th Annual Global Investment Conference: Fireside chat on September 11 at 11:30 a.m. ET
Live webcasts and archived recordings of these events will be available on Avadel's Investor Relations website for 90 days following each conference.
Avadel Pharmaceuticals (AVDL) has published results from a post-hoc analysis of their Phase 3 REST-ON clinical trial for LUMRYZ, a once-nightly sodium oxybate treatment for narcolepsy. The study, published in Clinical Therapeutics, showed that LUMRYZ use was associated with weight loss in narcolepsy patients.
Key findings include:
- LUMRYZ-treated participants lost a mean of 1.3 kg over 13 weeks, while placebo group gained 0.2 kg
- 17.8% of LUMRYZ group experienced ≥5% weight loss vs 3.8% in placebo group
- Significant BMI reduction observed in LUMRYZ group compared to placebo
- Weight loss group showed improvements in narcolepsy symptoms
These results suggest LUMRYZ may offer a tailored treatment approach for narcolepsy patients who are overweight or obese, addressing both core symptoms and weight management.
Avadel Pharmaceuticals (AVDL) reported strong Q2 2024 results, with $41.5 million in net revenue from LUMRYZ sales. The company saw significant growth in patient demand, with over 1,900 patients on LUMRYZ as of June 30th. Avadel is expanding its focus, having dosed the first patient in a Phase 3 trial for idiopathic hypersomnia and awaiting an FDA decision on LUMRYZ for pediatric narcolepsy by September 7, 2024.
Financial highlights include a gross profit of $38.7 million and a net loss of $13.8 million ($0.14 per diluted share). The company ended the quarter with $71.4 million in cash and equivalents. Avadel continues to invest in R&D and marketing efforts to support LUMRYZ's growth and potential new indications.
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company, has announced it will host a conference call and live webcast on August 8, 2024, at 8:30 a.m. ET. The event will provide a corporate update and discuss the company's financial results for the second quarter ended June 30, 2024. Investors can access the live audio webcast through the company's website, www.avadel.com. A replay will be available for 90 days following the event. Participants are encouraged to register for the conference call in advance, at least 10 minutes prior to the start time.
Avadel Pharmaceuticals (Nasdaq: AVDL) has announced the initiation of its Phase 3 REVITALYZ™ trial for LUMRYZ™ (sodium oxybate) in treating idiopathic hypersomnia (IH). The study, designed to evaluate the efficacy and safety of LUMRYZ as a once-at-bedtime dose, has dosed its first patient. The trial will enroll approximately 150 adults diagnosed with IH and includes an open-label extension.
The primary objective is to demonstrate reduced daytime sleepiness using the Epworth Sleepiness Scale (ESS) at Week 14. Secondary endpoints will assess additional efficacy parameters. Dr. Richard K. Bogan highlighted the significant unmet need in IH treatment, while Dr. Jennifer Gudeman emphasized the importance of this milestone for the IH community.
Avadel Pharmaceuticals (Nasdaq: AVDL) will join the Russell 3000® Index following the 2024 Russell US Indexes annual reconstitution, effective July 1, 2024. This inclusion highlights Avadel's growth and market presence, providing enhanced visibility among investors. CEO Greg Divis expressed pride in this milestone and emphasized its potential to boost the company's commercial launch of LUMRYZ, aiming to create long-term shareholder value. The Russell 3000® Index encompasses the 4,000 largest US stocks by market capitalization, with Avadel's inclusion facilitating entry into either the Russell 2000® or Russell 1000® Index, along with relevant growth and value style indexes. The Russell indexes are key benchmarks for investment managers, with $10.5 trillion in assets benchmarked against them as of December 2023.
Avadel Pharmaceuticals (Nasdaq: AVDL) has announced that its management will participate in two upcoming investor conferences. The company will join the Jefferies Global Healthcare Conference for a fireside chat on June 6 at 10:30 a.m. ET, and the Goldman Sachs 45th Annual Global Healthcare Conference for a fireside chat on June 12 at 3:20 p.m. ET. These events will be live-streamed and archived on Avadel's Investor Relations website for 90 days post-conference.
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