Late-Breaker Presentation for NOCTIVA™ Accepted for the 2018 American Urological Association Meeting

Truckee, CA (  -- Avadel Pharmaceuticals plc announced that new data from NOCTIVA’s pivotal Phase III clinical trials will be presented at the American Urological Association (AUA) 2018 annual meeting in San Francisco as a late-breaking presentation feature in the Next Frontiers plenary session. The presentation will share new data on extending the time to first uninterrupted sleep in elderly patients with nocturia following treatment with AV002 (NOCTIVA).

Mike Anderson, Avadel’s Chief Executive Officer, said, “As the first and only US approved nocturia therapy, NOCTIVA continues to demonstrate clinical benefit to a wide variety of patients in efficacy, safety and quality of life. We are pleased that the American Urology Association has recognized the importance of this critical information for the medical community and their patients.”

“Nocturia is a highly prevalent, under-recognized condition associated with disrupted sleep, which results in reduced productivity and negatively impacts health and quality of life1,[2],[3],[4],[5],[6],[7],[8].  Achieving 3-4 hours of uninterrupted sleep is a critical threshold for productivity9. Along with my co-authors, I look forward to sharing with my colleagues the exciting new findings in the elderly population, a particular group that disproportionately suffers from frequent nighttime urination,” said Dr. Benjamin Brucker MD, Assistant Professor of Urology and Obstetrics and Gynecology at New York University Langone Medical Center. “NOCTIVA has the potential to shift the current treatment paradigm for nocturia for the benefit of countless patients.”
NOCTIVA is the first and only product approved to treat nocturia due to nocturnal polyuria. Nocturnal polyuria is the overproduction of urine at night and can lead to nocturia, which causes a person to wake two or more times per night to void. It is estimated that nocturia impacts approximately 40 million Americans.10 


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3. Coyne KS, et al. BJU Int. 2003;92(9):948-954.
4. Holm-Larsen T. Neurourol Urodyn. 2014;33(Suppl 1):S10-14.
5. Kobelt G, et al. BJU Int. 2003;91(3):190-195.
6. Tikkinen KA, et al. Eur Urol. 2010;57(3):488-496.
7. Weiss JP. Rev Urol. 2012;14(3-4):48-55.
8. Abrams P. European Urology Supplements. 2005;3:6(1-7)
9. Stanley N. Eur Urol Suppl. 2005;4:17-19.
10. Bosch JLH, Weiss JP. The prevalence and causes of nocturia. J Urol. 2010;184(2):440-446.

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