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Avadel Pharmaceuticals Announces Acceptance of Late-Breaker Presentation for NOCTIVA™ at the 2018 American Urological Association
“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,,,,,,,. 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.
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
Details of the presentation:
Title: Extended First Uninterrupted Sleep Period in Elderly Patients Following Treatment with AV002, an Emulsified Low Dose Vasopressin Analog for Nocturia
Date and Time:
Track: Plenary: Next Frontier
Location: Room MCC NORTH, Hall E
NOCTIVA (desmopressin acetate) is an emulsified low dose vasopressin analog, approved by the
Important Safety Information and Indication for NOCTIVA (desmopressin acetate)
- NOCTIVA can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death.
- NOCTIVA is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
- Ensure serum sodium concentrations are normal before starting or resuming NOCTIVA. Measure serum sodium within seven days and approximately one month after initiating therapy or increasing the dose, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia.
- If hyponatremia occurs, NOCTIVA may need to be temporarily or permanently discontinued.
For full prescribing information, please click here.
Safe Harbor: This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “will,” “may,” “believe,” “expect,” “anticipate,” “estimate,” “project” and similar expressions, and the negatives thereof, identify forward-looking statements, each of which speaks only as of the date the statement is made. Although we believe that our forward-looking statements are based on reasonable assumptions within the bounds of our knowledge of our business and operations, our business is subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and our results of operations will not differ materially from the results contemplated in such forward-looking statements. These risks include: (i) risks that we may not achieve our goals of becoming a leading specialty pharma company, including by continuing to grow and broaden our offering of new and differentiated products, launch NOCTIVA, complete our REST-ON Phase III clinical trial, transform our company and drive long-term value creation; and (ii) the other risks, uncertainties and contingencies described in the Company's filings with the
Chief Financial Officer
Phone: (636) 449-1844
Sr. Director, Investor Relations and Corporate Communications
Phone: (636) 449-5866
1 Bliwise DL, et al. Sleep Med. 2009;10(5):540-548.
2 Chen F-Y, et al. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(4):431-436.
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.
Source: Avadel Pharmaceuticals plc