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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”
NOCTIVA, an emulsified microdose desmopressin, is the first and only product approved by
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 sleep3. 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
Additionally, physicians will present on behalf of Avadel during an AUA product theatre forum: “Noctiva: Addressing a Nighttime Condition with Daytime Consequences.” Nationally recognized thought leaders
Avadel representatives are available throughout the conference at booth number 5966. Please see the schedule below detailing Avadel’s presence at AUA:
|Title||Date and Time||Location||Presenter(s)|
|Extended First Uninterrupted Sleep Period in Elderly Patients Following Treatment with AV002, an Emulsified Low Dose Vasopressin Analog for Nocturia||Sunday, May 20 at 4:30 p.m. PDT
||Room MCC NORTH, Hall E||
|Noctiva: Addressing a Nighttime Condition with Daytime Consequences||Saturday, May 19 from 3-4 p.m. PDT||ICU Theater||
|Exhibition Booth||Saturday, May 19 from 9 a.m. – 6 p.m. PDT
Sunday, May 20 and Monday, May 21 from 9 a.m. – 4 p.m. PDT
|Hall D, booth number 5966||
NOCTIVA is an emulsified low dose vasopressin analog, approved by the
Important Safety Information 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.
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
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
Avadel Sr. Director, Investor Relations and Corporate Communications
Phone: (636) 449-5866
Phone: (415) 318-4043
1. Bosch JLH, Weiss JP. The prevalence and causes of nocturia. J Urol. 2010; 184(2):440-446.
2. Ancoli-Israel S, Bliwise DL, Nørgaard JP. The effect of nocturia on sleep. Sleep Med Rev. 2011 April; 15(2): 91-97
3. Stanley N. The underestimated impact of nocturia on quality of life. Eur Urol. 2005;4(7):17-19