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| |  FDA Approves DDAVP Tablets For Bed-Wetting COLLEGEVILLE, PA -- March 27, 1998 -- The United States Food and Drug Administration has granted marketing clearance to Rhone-Poulenc Rorer’s tablet formulation of DDAVP (desmopressin acetate) for the management of primary nocturnal enuresis (PNE), commonly known as bed-wetting, in patients aged six and over. DDAVP has been available in a nasal spray form for bed-wetting since its introduction in 1989. DDAVP is a synthetic form of vasopressin, an antidiuretic hormone normally made in the body. Vasopressin serves several roles, one of which is regulation of water balance and urine production. When the body needs more water in the blood stream, it produces higher levels of vasopressin. This results in more water being re-absorbed from the kidney and less urine production. Bed-wetting affects approximately five to seven million children in the U.S. and may be due to one or a combination of factors. Some studies suggest one factor that could play a role in pediatric bed-wetting is insufficient night-time quantities of an antidiuretic hormone. Research suggests that DDAVP reduces urine production in children who wet the bed by supplementing their natural level of anti-diuretic hormone. "Children who suffer from primary nocturnal enuresis have a condition that is often highly stigmatised," said Alan Greene, M.D., F.A.A.P., a primary care pediatrician in San Mateo, CA. and voluntary clinical instructor in the department of pediatrics at Stanford University School of Medicine. "Tablets are considered a more portable, discreet mode of administration than spray and are a desirable alternative for many patients." While the nasal spray formulation has been shown to be effective in controlling bed-wetting, the nasal route of drug administration may not be ideal for all patients. Nasal congestion may impede absorption of nasal spray. For some patients, the nasal spray can be difficult to administer. "A school-age child has on the average 10 upper respiratory tract infections or colds per year, as well as seasonal allergies, all of which can result in nasal congestion. This impairs absorption of a nasal spray," said Lori Semel, M.D., F.A.A.P., of Sound Shore Medical Center in New Rochelle, N.Y.. "Tablets may be easier and more convenient for patients and families." Patients with primary nocturnal enuresis who are currently on DDAVP Nasal Spray can be safely and effectively switched by their physicians to small, easy-to-swallow DDAVP Tablets. Patients previously using nasal spray can begin tablet therapy the next night. The initial recommended dose is 0.2 mg at bedtime and may be titrated to 0.6 mg to achieve the desired response. DDAVP Tablets for use in primary nocturnal enuresis are supplied in a 0.2 mg dosage strength. The only drug-related adverse event seen in three percent or more of patients was headache. Night-time fluids should be restricted to decrease the chance of fluid overload. More information on: Rhone-Poulenc Rorer.
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