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| |  New Orodispersible Formulation of Desmopressin Effective for Nocturnal Enuresis in Children: Presented at ICS By Alison Palkhivala MONTREAL, CANADA -- September 7, 2005 -- A new formulation of desmopressin that melts in the mouth is a safe and effective treatment for nocturnal enuresis in children, with a recommended dosing range between 60 and 240 mcg. Desmopressin is currently available in oral and nasal spray form for the treatment of nocturnal enuresis. It works by increasing urine concentration and decreasing urine production. The drug is manufactured by Ferring Pharmaceuticals under the trade name DDAVP(R). To test the new orodispersible formulation of desmopressin and obtain better pharmacokinetic data about its use in children, investigators in collaboration with Ferring performed a multicenter trial that tested six doses of the drug against a placebo. Lead investigator Guy Bogaert, MD, pediatric urology, UZ Gasthuisberg, Leuven, Belgium presented the results here September 1st at the 35th annual meeting of the International Continence Society (ICS). For the trial, children aged 6 to 12 with documented primary nocturnal enuresis were randomized in a double-blind fashion to treatment with a single dose of orodispensible desmopressin or a placebo. The active therapy was dosed at 30, 60, 120, 240, 360, or 480 mcg. Patients were overhydrated prior to taking their medication to suppress endogenous vasopressin production and ensure that antidiuresis was due to the treatment. Within an hour of taking the active therapy at any dose, urinary output dropped markedly. In addition, starting within 1 hour of drug administration, there was increased mean urine osmolality. In all dosage groups except the lowest one osmolality was greater than 800 mOsm/kg after 1 hour. Mean maximum urinary osmolality occurred 1 to 4 hours after drug administration and ranged from 515 to 957 mOsm/kg, depending on drug dose. In comparison, osmolality never reached more than 400 mOsm/kg in the placebo group. The duration of antidiuretic effect increased as the dose of desmopressin increased. Also, for all three threshold levels of osmolality (125, 200, and 400 mOsm/kg) there was dose-response relationship for the duration of urinary concentrating action. Based on the bioactivity data, the investigators suggest that a 60 mcg dose of desmopressin would be best for patients requiring an effect early in the night, while 120 mcg or more might be best for those requiring an effect later in the night. "We aim for a duration [of action] between 6 and 11 hours, which is good for both efficacy and safety, because you want it to stop in the morning when the children start drinking again," said Dr. Bogaert during his talk. "120 mcg is the lowest dose that reaches this effect." He recommended a therapeutic range between 120 and 240 mcg for children. According to Lone Hoedt Hansen, MSc, PhD, Clinical Research Manager at Ferring, the orodispersible formulation of desmopressin is currently under regulatory investigation and is expected to be available in North American within a year or so.
[Presentation title: A Pharmacodynamic Study in Children With Primary Nocturnal Enuresis Using a New 'Melt' Orodispersible Formulation of Desmopressin. Abstract 114]
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