The Medical Letter on Drugs and Therapeutics
FROM
ISSUE 1568
ISSUE 1568
March 25, 2019
Desmopressin (Nocdurna and Noctiva) for Nocturnal Polyuria
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March 25, 2019 (Issue: 1568)
The FDA has approved a sublingual tablet (Nocdurna –
Ferring) and a nasal spray (Noctiva – Avadel) formulation
of desmopressin acetate for treatment of nocturia due to
nocturnal polyuria in adults who wake up ≥2 times per
night to void. Nocdurna and Noctiva are the first two
products to be approved in the US for this indication.
Higher-strength nasal spray and oral tablet formulations
of desmopressin (DDAVP, and others) have been available
for years for treatment of diabetes insipidus and primary
nocturnal enuresis (bedwetting in children). In 2007, the
indication for primary nocturnal enuresis was removed
from the labels of the nasal spray formulations because
their use resulted in 61 cases of hyponatremia-related
seizures, 2 of which resulted in death.
... more
- M Oelke et al. A practical approach to the management of nocturia. Int J Clin Pract 2017 October 5 (epub).
- CG Kowalik et al. Nocturia: evaluation and current management strategies. Rev Urol 2018; 20:1.
- PK Sand et al. Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol 2013; 190:958.
- JP Weiss et al. Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol 2013; 190:965.
- J Kaminetsky et al. Efficacy and safety of SER120 nasal spray in patients with nocturia: pooled analysis of 2 randomized, double-blind, placebo controlled, phase 3 trials. J Urol 2018; 200:604.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. March 5, 2019. Reprinted with permission by First Databank, Inc. All rights reserved. ©2019. www.fdbhealth.com/policies/drug-pricing-policy.

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