Avadel to Present Late-Breaker Data and Product Theater Forum at the 2018 American Urological Association Annual Meeting

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Data demonstrates extended first uninterrupted sleep period in elderly patients

Key opinion leaders to present “NOCTIVA™: Addressing a Nighttime Condition with Daytime Consequences”

DUBLIN, Ireland, May 18, 2018 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq:AVDL), “Avadel” or the “Company,” will release research findings from the Phase III clinical trials of AV002 at the American Urological Association (AUA) Annual Meeting in San Francisco on May 20, 2018 that demonstrate elderly nocturia patients treated with AV002 – , an emulsified microdose of desmopressin – have a longer first period of uninterrupted sleep at night, and wake less often to urinate.

Benjamin M. Brucker, MD, a specialist in urology and female pelvic medicine at New York University’s Langone Medical Center and an expert on nocturia, will unveil the data from NOCTIVA’s pivotal Phase III clinical trials. The abstract, “Extended First Uninterrupted Sleep Period in Elderly Patients Following Treatment with AV002, an Emulsified Low Dose Vasopressin Analog for Nocturia,” will be presented during the Next Frontiers plenary session.

NOCTIVA, an emulsified microdose desmopressin, is the first and only product approved by FDA to treat nocturia due to nocturnal polyuria in adults. Nocturnal polyuria is the overproduction of urine at night and can lead to nocturia, a condition causing patients to wake two or more times per night to urinate. Nocturia affects an estimated 40 million Americans and can cause patients to suffer reduced productivity, and negatively impacts overall health and health-related quality of life.

Clinical trials for NOCTIVA were conducted in patients with a history of two or more nocturic episodes per night and with an average baseline time to first nocturic episode of 2.4 hours. Patients were randomized into three groups and received either 1.66 mcg or 0.83 mcg of NOCTIVA or a placebo for 12 weeks. Dr. Brucker’s presentation provides a sub-group analysis of these trial results, stratified into two age groups: patients ages 65 years and older and patients 75 years and older. The results demonstrated that patients on either strength of NOCTIVA stayed in bed longer before experiencing a nocturic episode. For example, on average, trial participants 65 years and older on the 1.66 mcg dose were able to stay in bed over four hours before experiencing their first nocturic episode, surpassing the four-hour critical threshold for restful sleep.  These results represented an average improvement greater than 50% relative to placebo over the 2.4-hour baseline. Further, trial participants who took either dose of NOCTIVA recorded 32% - 43% more nights with one or fewer episodes, depending on age (relative to mean nocturic episodes baseline of 3.2 – 3.4 per night at screening).

“We understand how disruptive nocturia can be for patients and are proud to have recently launched NOCTIVA, the first product determined by FDA to be safe and effective for treatment of nocturia due to nocturnal polyuria,” said Greg Divis, Chief Operating Officer of Avadel. “We’re excited to share this very pertinent data at AUA with industry leaders who can have a direct impact on nocturia patients’ quality of life.”

Additionally, physicians will present on behalf of Avadel during an AUA product theatre forum: “.” Nationally recognized thought leaders Diane K. Newman, DNP, FAAN, Co-director of Penn Center for Continence and Pelvic Health; Scott A. MacDiarmid, MD, FRCPSC, Urologist with Moses H. Cone Memorial Hospital; Jennifer Miles-Thomas, MD FPMRS, Assistant Professor of Urology and Medical Director of the Pelvic Health Center at Chesapeake Regional Medical Center; and Thomas Roth, PhD, Director of the Henry Ford Hospital Sleep Center, will discuss the impact of nocturia on patients and ongoing efforts to diagnose and treat the condition.

Avadel representatives are available throughout the conference at booth number 5966. Please see the schedule below detailing Avadel’s presence at AUA:

 

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Globe Newswire: 16:00 GMT Friday 18th May 2018

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