Article: New indications: DDAVP

Tablet formulation approved to treat primary nocturnal enuresis

The tablet formulation of desmopressin acetate (DDAVP, RhonePoulenc Rorer Pharmaceuticals Inc) has received FDA approval to treat primary nocturnal enuresis (PNE), or bed-wetting. The antidiuretic hormone may be used alone or as an adjunct to behavioral conditioning or other nonpharmacologic intervention. The intranasal formulation of this agent had been previously approved for this indication.

Approval was based on two double-blind, randomized, placebo-controlled studies. In the first of these, patients (329 assessable; age range: 5 to 17 years) received 2 weeks of therapy with one of three doses of DDAVP (0.2, 0.4, or 0.6 ...

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