Explore efficacy

See how NOCTIVA reduced the impact of nocturia due to nocturnal polyuria in 2 clinical trials.1

NOCTIVA™ (desmopressin acetate) Nasal Spray set a new standard for the definition of responder1-3

In two 12-week clinical trials, NOCTIVA set a 50% reduction in nocturic episodes per night as its “responder” threshold (the highest of any FDA-approved nocturia treatment).1-3

Percentage of Patients achieving a 50% or more reduction in nocturic episodes per night1
Asset 1
  • 48.0%a

    NOCTIVA 1.66 mcg
    (pooled data)

  • 37.3%b

    NOCTIVA 0.83 mcg
    (pooled data)

  • 27.5%

    Placebo
    (pooled data)

aP<.0001 vs placebo. bP=.0055 vs placebo.

NOCTIVA 1.66 mcg
Trial 1 (n=199) Trial 2 (n=143)
47% of patients 49% of patients
Difference from placebo (95% CI)
21% (12% to 30%) 20% (9% to 31%)
NOCTIVA 0.83 mcg
Trial 1 (n=209) Trial 2 (n=145)
35% of patients 41% of patients
Difference from placebo (95% CI)
8% (-0.4% to 17%) 12% (1% to 23%)
Placebo
Trial 1 (n=204) Trial 2 (n=145)
27% of patients 29% of patients
In the NOCTIVA 1.66 mcg group, nearly 50% of patients got at least 50% better.1

NOCTIVA significantly reduced nighttime urine production3

MEAN REDUCTION IN NOCTURNAL URINE VOLUME (mL)3

-301.8 mL
reductiona
-239.0 mL
reductionb
-189.5 mL
reduction

NOCTIVA 1.66 mcg

(n=298) (pooled data) Baseline=804.8 mL

NOCTIVA 0.83 mcg

(n=318) (pooled data) Baseline=804.9 mL

Placebo

(n=326) (pooled data) Baseline=804.8 mL

NOCTIVA 1.66 mcg

(n=298) (pooled data) Baseline=804.8 mL

NOCTIVA 0.83 mcg

(n=318) (pooled data) Baseline=804.9 mL

Placebo

(n=326) (pooled data) Baseline=804.8 mL

aP<.0001 vs placebo.   bP=.0395 vs placebo

aP<.0001 vs placebo.
bP=.0395 vs placebo.

Responders produced 360.1 mL less urine than at baseline.3 That’s almost a full bladder.4
1.66 mcg treatment group (n=149)

NOCTIVA gave patients over 4 hours of uninterrupted sleep3

CHANGE IN TIME FROM BEDTIME TO FIRST NOCTURIC VOID OR FIRST MORNING VOID3*

  • Mean time from bedtime to first nocturic void at week 12 (pooled) for first morning void in the absence of nocturic void.

aP<.0001 vs placebo.

Responders stayed in bed an average of 2.9 hours longer, giving them over 5 hours before they woke up to void for the first time.3
1.66 mcg treatment group (n=164)
NOCTIVATM (desmopressin acetate) Nasal Spray 0.83 mcg set on nightstand next to bed

With NOCTIVA, some nights were completely free of void1

Many patients taking NOCTIVA only woke up once per night to void, and some were able to sleep through the night.1

FOR NOCTIVA RESPONDERS,

73%*

of nights had 0 or 1 nocturic void3
(1.66 mcg; n=164).

19%*

of nights were completely void-free3
(1.66 mcg; n=164).

*Change from baseline.

CHANGE FROM BASELINE IN PERCENTAGE OF NIGHTS WITH AT MOST 1 NOCTURIA EPISODE1

(all patients with nocturnal polyuria)

  NOCTIVA 1.66 mcg NOCTIVA 0.83 mcg Placebo
  Trial 1 Trial 2 Trial 1 Trial 2 Trial 1 Trial 2
Baseline 1% 1% 1% 2% 1% 1%
Change from baseline 44% 45% 40% 40% 34% 30%
Number of patients 199 143 209 145 204 145
95% CI 2% to 17% 6% to 23% -1% to 13% 1% to 18% - -
With NOCTIVA, your patients could experience a full night’s sleep.1

Take action

Many of your patients could be waking up tonight because of nocturia due to nocturnal polyuria. With NOCTIVA, you could reduce its impact.1

Take action

Many of your patients could be waking up tonight because of nocturia due to nocturnal polyuria. With NOCTIVA, you could reduce its impact.1

Next up

See how NOCTIVA demonstrated tolerability across studies.1,3

Safety
REFERENCES

1. NOCTIVA [package insert]. Chesterfield, MO: Avadel Specialty Pharmaceuticals, LLC; 2017. 2. Cohn JA, Kowalik CG, Reynolds WS, et al. Desmopressin acetate nasal spray for adults with nocturia. Expert Rev Clin Pharmacol. 2017;10(12):1281-1293. 3. Data on file. Avadel Specialty Pharmaceuticals, LLC. 4. Lukacz ES, Sampselle C, Gray M, et al. A healthy bladder: a consensus statement. Int J Clin Pract. 2011;65(10):1026-1036. 5. Stanley N. The underestimated impact of nocturia on quality of life. Eur Urol. 2005;4(7)(suppl):17-19.

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INDICATION AND IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: HYPONATREMIA

See full prescribing information for complete boxed warning.

  • 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.

Contraindications
  • Hyponatremia or a history of hyponatremia
  • Polydipsia
  • 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.
Adverse Reactions

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.

Drug Interactions

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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION AND IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: HYPONATREMIA

See full prescribing information for complete boxed warning.

  • 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.

Contraindications
  • Hyponatremia or a history of hyponatremia
  • Polydipsia
  • 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.
Adverse Reactions

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.

Drug Interactions

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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.