RPR Launches DDAVP(tm) Tablets for Central Diabetes Insipidus (CDI)

RPR Launches DDAVP(tm) Tablets for Central Diabetes Insipidus (CDI)


COLLEGEVILLE, Pa., Feb. 8, 1996 -- Rhone-Poulenc Rorer Inc. (NYSE: RPR) today announced that it has received Food and Drug Administration (FDA) clearance to market a tablet formulation of DDAVP (desmopressin acetate) for the treatment of central diabetes insipidus (CDI). DDAVP is a synthetic analog of vasopressin, an antidiuretic hormone affecting renal water conservation.

Currently, CDI can be treated with DDAVP in liquid form, delivered through a rhinal tube. Although the rhinal tube is a clinically effective treatment mode, DDAVP(TM) Tablets may offer a more convenient method of administration for those patients who must take the medication frequently.

Diabetes insipidus (DI) is a rare metabolic disorder in which patients produce large quantities of dilute urine and are constantly thirsty. CDI is caused by a deficiency in the amounts of the hormone vasopressin secreted from the pituitary gland, and can be caused by disease of the gland, or by injury to the gland such as head trauma, surgery, or tumors. The condition can be acute and short in duration or it can be a chronic, life-long problem.

"People who suffer from CDI have a condition that requires constant monitoring. Many patients face a lifetime of medicine," said Abbey Meyers, President of the National Organization for Rare Disorders (NORD). "Many of these chronic users of the intranasal route have complained about the inconvenience and difficulty of rhinal tube dosing. Oral tablet therapy is a more desirable alternative for many patients, and could be even more effective because it may increase patient compliance. We encourage CDI patients to see their physicians and inquire about the new DDAVP(TM) Tablets."

Patients with CDI who are currently on DDAVP Intranasal therapy can be safely and effectively switched by their physicians to new, easy to swallow DDAVP(TM) Tablets, with appropriate monitoring of urine concentrations and thirst.

Rhone-Poulenc Rorer Pharmaceuticals Inc.'s DDAVP(TM) Tablet formulation is the first orally available peptide to be absorbed from the intestine and circulated in an intact form, making it possible to achieve the desired antidiuretic effect. Previous attempts to obtain absorption of peptides after oral administration had generally been unsuccessful.

Central diabetes insipidus is an extremely rare condition. According to the National Center for Health Statistics, there were 11,000 hospital discharges in the United States in 1992. The number of CDI patients on therapy outside of the hospital setting is more difficult to measure.

The onset of antidiuretic effect occurs at around one hour with DDAVP(TM)Tablets, and optimal antidiuretic effects last up to eight hours with doses of 0.1 mg to 0.2 mg, and up to 12 hours with a 0.4 mg dose. DDAVP(TM) Tablets are supplied in 0.1 mg and 0.2 mg dosage strengths.

Rhone-Poulenc Rorer Inc. is a global pharmaceutical company dedicated to improving human health. The company reported sales of $5.14 billion, and invested more than $750 million in research and development, in 1995.

CONTACT: Kathryn Metcalfe of Noonan/Russo Communications, 212-696-4455, ext. 206, or Email, mail@noonanrusso.com, or Rob Partridge of Rhone-Poulenc Rorer, 610-454-3890, or Email, partrrg@rpr.rpna.com / /Rhone-Poulenc Rorer press releases available through Company News On-Call by fax, 800-758-5804, ext. 764050, or at http://www.prnewswire.com / (RPR)


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