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Avadel Pharmaceuticals Announces Data Supporting Clinical Profile for LUMRYZ™ at SLEEP 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
By: GlobeNewswire - 31 May 2023 | Back to overview list |
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– 12 accepted abstracts highlight Company’s emerging leadership in narcolepsy – – Data adds to growing body of evidence demonstrating positive clinical benefit and patient preference of once-at-bedtime LUMRYZ – – Company to support symposium on June 6 with leading KOLs discussing unmet needs in the advancement of narcolepsy treatment – DUBLIN, May 31, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced new data supporting the clinical profile for LUMRYZ™ (sodium oxybate) for extended-release oral suspension (CIII) and patient preference for a once-nightly oxybate in 12 abstracts, including six oral presentations, at SLEEP 2023, the 37th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, being held from June 3-7, 2023 in Indianapolis. LUMRYZ (previously known as FT218), is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. LUMRYZ was granted U.S. Food and Drug Administration (FDA) approval in May 2023, and is the first and only FDA approved once-at-bedtime oxybate for people living with narcolepsy. LUMRYZ was granted Orphan Drug Exclusivity, as the Office of Orphan Product Development identified LUMRYZ to be clinically superior to immediate release oxybates based upon the major contribution to patient care that LUMRYZ provides by way of its once-nightly dosing. “We are thrilled to attend SLEEP 2023 and present a broad range of data further supporting the clinical value proposition of LUMRYZ as a once-nightly option to manage EDS and cataplexy in narcolepsy, including data from our RESTORE and REST-ON trials,” said Jennifer Gudeman, PharmD, Senior Vice President, Medical and Clinical Affairs of Avadel. “Additionally, presentations at this year’s conference also include insights gleaned from MyNarcolepsyTeam, where people with narcolepsy reported the need for relief from both daytime and nighttime symptoms. With final approval of LUMRYZ, we’re proud to offer the narcolepsy community a once-at-bedtime treatment option for cataplexy or excessive daytime sleepiness (EDS) that removes the burden of twice-nightly dosing and provides the opportunity for an uninterrupted night’s sleep.” LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting. Highlights from the presentations include:
All abstracts have been published in an online supplement in the journal Sleep. Presentation details are as follows:
The symposium will feature panel presentations from Anne Marie Morse, D.O., Director of Child Neurology and Pediatric Sleep Medicine at Geisinger Medical Center at Janet Weis Children’s Hospital; Yves Dauvilliers, M.D., Ph.D., Director of the Sleep and Wake Disorders Centre in the Department of Neurology at the Gui de Chauliac Hospital in Montpellier, France; Michael J. Thorpy, M.D., Director of the Sleep-Wake Disorders Center at Montefiore and Professor of Neurology at Albert Einstein College of Medicine; Clete Kushida, M.D., Ph.D., Division Chief and Medical Director of Stanford Sleep Medicine, neurologist and Professor in the Department of Psychiatry and Behavioral Sciences at Stanford University Medical Center and Director of the Stanford Center for Human Sleep Research at Stanford University. In addition, the panel will include a person with narcolepsy, enrolled in the open-label RESTORE study since September 2020, who will speak about her clinical trial experience. About Avadel Pharmaceuticals plc About LUMRYZ™ (sodium oxybate) for extended-release oral suspension The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians’ overall assessment of patients’ functioning (CGI-I) and cataplexy attacks, for all three evaluated doses when compared to placebo.?? With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. IMPORTANT SAFETY INFORMATION
It is not known if LUMRYZ is safe and effective in people less than 18 years of age. Do not take LUMRYZ if you take other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase deficiency. Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you. Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized. LUMRYZ can cause serious side effects, including the following:
Tell your doctor if you are on a salt-restricted diet or if you have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you. The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see full Prescribing Information, including BOXED Warning. Cautionary Disclosure Regarding Forward-Looking Statements The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 29, 2023, and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Investor Contact: Media Contact: |
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