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Avadel Pharmaceuticals Presents Data for NOCTIVA at 2018 American Urogynecologic Society Annual Scientific Meeting
Data demonstrate significant improvement in number of nights with one or no nocturic episodes and extended first uninterrupted sleep period in patients suffering from nocturia due to nocturnal polyuria
NOCTIVA is a proprietary emulsified formulation of desmopressin that uses a unique permeation enhancer and nasal administration to deliver a microdose of desmopressin. It is the lowest effective dose of desmopressin approved by the
Poster #50: Extended First Uninterrupted Sleep Period in Nocturia Patients with Nocturnal Polyuria Following Treatment with AV002, an Emulsified Microdose Vasopressin Analog Nasal Spray for Nocturia
The efficacy of NOCTIVA on FUSP and safety, as secondary endpoints, were evaluated in patients age 50 years and older with nocturia due to nocturnal polyuria in two Phase 3 randomized, double-blind pivotal studies. FUSP is defined as elapsed time from bedtime to first NOV or awakening if no void occurred. Patients were randomized into three groups and received either 1.66 mcg or 0.83 mcg of NOCTIVA, or a placebo for 12 weeks. The baseline average FUSP for all groups was 2.4 hours.
In the NOCTIVA 1.66 mcg group, FUSP increased by 1.8 hours to 4.2 hours, and in the NOCTIVA 0.83 mcg group, FUSP increased by 1.6 hours to 4.0 hours, which was statistically significant compared to placebo. Incidence and severity of adverse events were similar to placebo, and the incidence of hyponatremia, defined as serum sodium ≤125 mmol/L regardless of symptoms or <130 mmol/L with symptoms, was low for both doses. No patients treated with 0.83 mcg experienced serum sodium ≤125 mmol/L. These results demonstrate that NOCTIVA is an effective therapy with a well-tolerated safety profile in patients with nocturia due to nocturnal polyuria and may provide longer periods of uninterrupted sleep.
Poster #51: Increase in Percentage of Nights with ≤ 1 Nocturic Void per Night in Nocturia Patients with Nocturnal Polyuria Following Treatment with AV002, an Emulsified Microdose Vasopressin Analog Nasal Spray for Nocturia
In two Phase 3 randomized, double-blind pivotal studies, the efficacy of NOCTIVA on percentage of nights with one to zero NOVs, and a secondary endpoint of safety, were assessed in patients age 50 years and older with nocturia due to nocturnal polyuria. Zero to one NOV per night is considered normal. Patients were randomized into three groups and received either 1.66 mcg or 0.83 mcg of NOCTIVA, or a placebo for 12 weeks. At baseline for all study participants, the average number of nights with one or no NOVs was only one percent (calculated on a per-patient basis for six out of 14 nights).
In the NOCTIVA treatment groups, the percentage of nights with one to zero NOVs increased from one percent to 45 percent for 1.66 mcg group, and to 41 percent for 0.83 mcg group, which was statistically significant compared to placebo. Incidence and severity of adverse events were similar to placebo, and the incidence of hyponatremia, defined as serum sodium ≤125 mmol/L regardless of symptoms or <130 mmol/L with symptoms, was low for both doses. No patients treated with 0.83 mcg experienced serum sodium ≤125 mmol/L. These results show that NOCTIVA is an effective therapy with a well-tolerated safety profile in patients with nocturia due to nocturnal polyuria.
“Disturbance of restorative sleep can have serious consequences on your health and quality of life. Returning to normal levels of nighttime voids is key to improving quality of sleep and function during the day. These studies demonstrate that NOCTIVA is an effective therapy with a well-tolerated safety profile for patients suffering with nocturia due to nocturnal polyuria,” said
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. ,,,,,,
NOCTIVA is an emulsified microdose vasopressin analog nasal spray, approved by the
See full prescribing information for complete boxed warning.
Important Safety Information for NOCTIVA (desmopressin acetate) Nasal Spray
- 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 NOCTIVA™ 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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