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CLINICAL DATA/EVIDENCE

DesmoMelt (desmopressin [as acetate] oral lyophilisate) is a sublingual oral lyophilisate formulation of desmopressin which quickly dissolves when taken1,2. It is indicated for the treatment of primary nocturnal enuresis (PNE) in children and adults aged 5 to 651.

DesmoMelt is well accepted by children of various ages and facilitates early intervention2, providing an effective and convenient solution to PNE and helping children and families return to a normal life.

Children aged 5-11 years prefer DesmoMelt to tablets2

 

A statistically significant preference for DesmoMelt has been shown in children aged 5-11 years2. (For patients
<12 years, 60.6% patients preferred the melt formulation [p=0.009])2

  • DesmoMelt dissolves under the tongue, removing the difficulty children may face swallowing a tablet2
  • High compliance is associated with DesmoMelt; 94.5% of patients showed ≥80% compliance during a six-week long study2

 

DesmoMelt provides a superior and longer duration of action 3-8 hours after dosing3

Compared with tablets, DesmoMelt provides a significantly superior antidiuretic effect and concentrating capacity 3-8 hours after dosing3.

 

Due to the superior pharmacodynamic characteristics of the melt formulation, more than 25% of patients had a higher diuresis rate with the tablet vs. melt formulation3. Patients with the melt formulation produced less urine over the same time period (results based on urine collected in the plateau phase at hours 3-5 [p<0.02], and in action at hours 5-8 [p<0.005])3

Switching from tablet to DesmoMelt is associated with increased efficacy and compliance4

The probability of a reduction in bedwetting episodes is twice as likely with DesmoMelt4

 

  • One study shows a two-fold likelihood that a child will experience a dry night when taking desmopressin melt over tablet4. This suggests a clinical benefit for switching to the sublingual formulation4.

 

Fluid intake is not required with drug administration2

Tablet consumption may require 60 mL of water (approximately a quarter of the expected bladder capacity of a 7 year old) which may also impact the efficacy of desmopressin4.

  • De Guchtenaere, et al. suggest that the melt formulation could cause a 72 mL reduction in urine during the studied time interval; this in turn, might mean the difference between waking up wet or dry3

A single dose (120mcg) of DesmoMelt should be taken before bedtime for a period of 3 months, followed by a one-week drug-free period to assess results. If symptoms persist, the treatment cycle should be repeated1.

  • If needed, the dose taken can be increased to 240mcg1

 

For more information about the benefits of DesmoMelt, download our short leaflet.

Safety Profile

Side-effects include; headache (common (≥ 1/100 to < 1/10), stomach pain and nausea (≥ 1/1,000 to < 1/100). Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.

For further information on the safety profile of DesmoMelt please refer to the full SmPC DesmoMelt 120mcg oral lyophilisate – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)

  1. DesmoMelt Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/17268. Date accessed: March 2023.
  2. Lottman H et al. Int J Clin Pract 2007;61(9):1454–60.
  3. De Guchtenaere A et al. J Urol 2011;185(6):2308–13.
  4. Juul KV et al. Eur J Ped 2013;172(9):1235–42.

Job Code: UK-MN-2200029 - Date of preparation: June 2024

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