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These data were presented at oral sessions by key opinion leaders in the field of urology. The abstracts were entitled, “Extended first uninterrupted sleep period for older adults following treatment with AV002, an emulsified microdose vasopressin analog,” and “Rapid nocturia efficacy of AV002, an emulsified microdose vasopressin analog,” and were presented by
NOCTIVA, a proprietary emulsified formulation designed to deliver a microdose of desmopressin, is the first treatment approved by the
Extended first uninterrupted sleep period for older adults following treatment with AV002, an emulsified microdose vasopressin analog
Phase III clinical trials evaluating NOCTIVA included approximately 55 percent of patients age 65 and older with a history of two or more nocturic episodes per night and an average baseline FUSP between 2.4-2.5 hours. These patients were randomized into three groups and received either 1.66 mcg or 0.83 mcg of NOCTIVA or a placebo for 12 weeks. Sub-group analyses of the patients age 65 and older and 75 and older treated with NOCTIVA demonstrated a statistically significant reduction in nocturic episodes and extended FUSP compared to placebo. For both age groups, the mean FUSP after treatment was greater than four hours for the 1.66 mcg group and approximately four hours for the 0.83 mcg group. The impact of nocturia in patients from both cohorts was also evaluated using INTU (Impact of Nighttime Urination), a validated consultation tool developed with the
Rapid nocturia efficacy of AV002, an emulsified microdose vasopressin analog
Phase III clinical trials for NOCTIVA were conducted in patients with a history of two or more nocturic episodes per night and with an average baseline FUSP between 2.3 to 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. Following the first dose, patients treated with NOCTIVA had a significantly greater mean reduction in NOV and longer FUSP compared to placebo. The first period of sleep averaged more than four hours in the NOCTIVA patients. The results show that NOCTIVA has a rapid onset of effect with efficacy after the first dose and was well-tolerated throughout the duration of the study in patients seeking treatment for nocturia due to nocturnal polyuria.
“These results demonstrate that NOCTIVA is an effective therapy with a well-tolerated safety profile in older adults with nocturia. Disturbance of sleep has a profound impact on health and quality of life. Nocturia patients usually get up to void 2 to 2.5 hours after going to sleep, thus disturbing the important period of restorative sleep. These studies indicate that treating nocturia in older patients prolongs sleep and improves how patients feel and function during the day,” said
Details of the Presentations are as Follows:
|Title||Date and Time||Location||Presenter|
|No. 7 Extended first uninterrupted sleep period for older adults following treatment with AV002, an emulsified microdose vasopressin analog||Wednesday, August 29 at 8:35 a.m. EDT||Hall B||Benjamin M. Brucker, M.D., urologist and director of the Center of Female Pelvic Medicine at New York University’s Langone Health|
|No. 18 Rapid nocturia efficacy of AV002, an emulsified microdose vasopressin analog||Wednesday, August 29 at 9:57 a.m. EDT||Hall B||Diane K. Newman, DNP, FAAN, co-director of Penn Center for Continence and Pelvic Health|
Nocturia is a highly prevalent, under-recognized condition associated with disrupted sleep, which results in reduced productivity and negatively impacts health and quality of life. 3,,,,,,
NOCTIVA is an emulsified microdose vasopressin analog, approved by the
See full prescribing information for complete boxed warning.
Important Safety Information for NOCTIVA (desmopressin acetate)
- NOCTIVA can cause hyponatremia, which may be life-threatening if severe.
- 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 is 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.
INDICATIONS AND USAGE
NOCTIVA is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.
Limitation of Use: Not studied in patients younger than 50 years of age.
- Hyponatremia or a history of hyponatremia
- Primary nocturnal enuresis
- Concomitant use with loop diuretics or systemic or inhaled glucocorticoids
- Estimated glomerular filtration rate below 50 mL/min/1.73 m2
- Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
- During illnesses that can cause fluid or electrolyte imbalance
New York Heart Association(NYHA) Class II-IV congestive heart failure
- Uncontrolled hypertension
WARNINGS AND PRECAUTIONS
- Fluid retention: Not recommended in patients at risk of increased intracranial pressure or history of urinary retention. Monitor volume status in patients with NYHA Class I congestive heart failure.
- Nasal conditions: Discontinue in patients with concurrent nasal conditions that may increase absorption, until resolved.
Common adverse reactions in clinical trials (incidence >2%) included nasal discomfort, nasopharyngitis, nasal congestion, sneezing, hypertension / blood pressure increased, back pain, epistaxis, bronchitis and dizziness.
Monitor serum sodium more frequently when NOCTIVA is concomitantly used with drugs that may cause water retention and increase the risk for hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, nonsteroidal anti-inflammatories, lamotrigine and carbamazepine).
USE IN SPECIFIC POPULATIONS
- Pregnancy: Use of NOCTIVA is not recommended.
- Pediatric: Do not use NOCTIVA for primary nocturnal enuresis in children.
To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or
Please see the full Prescribing Information for NOCTIVATM at www.Noctiva.com/prescribing-information.
Avadel Sr. Director, Investor Relations and Corporate Communications
Phone: (636) 449-5866
Phone: (202) 591-4045
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2 Ancoli-Israel S, Bliwise DL, Nørgaard JP. The effect of nocturia on sleep. Sleep Med Rev. 2011 April; 15(2): 91-97.
3 Bliwise DL, et al. Sleep Med. 2009;10(5):540-548.
4 Coyne KS, et al. BJU Int. 2003;92(9):948-954.
5 Holm-Larsen T. Neurourol Urodyn. 2014;33(Suppl 1):S10-14.
6 Kobelt G, et al. BJU Int. 2003;91(3):190-195.
7 Tikkinen KA, et al. Eur Urol. 2010;57(3):488-496.
8 Weiss JP. Rev Urol. 2012;14(3-4):48-55.
9 Abrams P. European Urology Supplements. 2005;3:6(1-7).