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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) published findings in Brain Sciences revealing significant challenges faced by narcolepsy patients using twice-nightly sodium oxybate therapy. The study combined social media analysis and survey results from 87 U.S. adults.
Key findings showed that 75.3% of respondents reported accidentally missing their second dose, with 37% missing it weekly or more often. Nearly three-fourths reported improper timing of their second dose, with 58.8% taking it too late and 21.2% too early. Notably, 31.8% experienced injuries after waking for their second dose.
The study highlighted that inconsistent adherence leads to poor sleep quality, excessive daytime sleepiness, and decreased productivity. 75.9% of respondents agreed that a once-nightly dose would be safer than twice-nightly formulations.
Avadel Pharmaceuticals (Nasdaq: AVDL) has announced its upcoming participation in the Jefferies London Healthcare Conference. The company's management will engage in a fireside chat on Wednesday, November 20 at 7:30 a.m. GMT / 2:30 a.m. ET. Interested parties can access a live webcast of the discussion through Avadel's Investor Relations website at investors.avadel.com, where the recording will remain available for 90 days after the conference.
Avadel Pharmaceuticals reported strong Q3 2024 results with $50.0 million in net revenue from LUMRYZ sales. The company reached 2,300 patients on LUMRYZ by September 30th, adding 700 new patients in Q3. Key developments include FDA approval for LUMRYZ in patients 7 years and older with narcolepsy, granted Orphan Drug Exclusivity through October 2031. The company reported a minimal operating loss of $0.3 million and a net loss of $2.6 million ($0.03 per share). Cash position stood at $65.8 million as of September 30, 2024.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced it will host a conference call and live webcast on November 12, 2024, at 8:30 a.m. ET to discuss its third quarter 2024 financial results and provide a corporate update. The conference call can be accessed by dialing (800) 579-2543 with conference ID AVADEL. A live webcast will be available on the company's investor relations website, and a replay will be archived for 90 days.
Avadel Pharmaceuticals (Nasdaq: AVDL) announced a favorable U.S. District Court ruling upholding the FDA's approval of LUMRYZ, the first once-at-bedtime oxybate treatment for narcolepsy. The Court ruled against Jazz Pharmaceuticals' challenge under the Administrative Procedure Act, confirming LUMRYZ's clinical superiority to Jazz's twice-nightly oxybate products. The decision maintains LUMRYZ's Orphan Drug Exclusivity granted in May 2023 and validates its unique dosing schedule as a significant advancement in patient care.
Avadel Pharmaceuticals (AVDL) and nference published real-world data in Sleep Advances analyzing demographic characteristics and comorbidities in narcolepsy patients. The study, based on electronic health data from over 2,000 narcolepsy patients and 2,000 matched controls through Mayo Clinic Platform, revealed that people with narcolepsy were more likely to have psychiatric, sleep, and pain disorders. Unlike previous claims-based studies, cardiovascular disease was not among the top 20 comorbidities. This marks the first real-world study in narcolepsy using aggregate electronic health record data.
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.
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