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NDA Submitted to FDA for Conivaptan Hydrochloride To Treat Hyponatremia
PARAMUS, N.J., Feb. 2 /PRNewswire/ -- Yamanouchi Pharma America, Inc., a subsidiary of Yamanouchi Pharmaceutical Co., Ltd., a leading pharmaceutical company in Japan, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for conivaptan hydrochloride, a novel, dual V1a/V2 vasopressin receptor antagonist. The application contains clinical data from three double-blind, placebo-controlled, randomized, multi-center studies conducted in the United States and internationally to support the use of conivaptan for the treatment of hyponatremia, a potentially life-threatening condition that occurs when the body's blood sodium level falls below normal.
"Conivaptan is a novel pharmaceutical agent in a new class of drugs being developed specifically for the treatment of hyponatremia, a serious condition for which available treatment is limited or suboptimal," said Akihiko Matsubara, President and Chief Operating Officer of Yamanouchi Pharma America, Inc. "The submission for conivaptan is another important step in fulfilling our goal of becoming a fully integrated pharmaceutical company in the U.S. market."
Developed by Yamanouchi, conivaptan is expected to become the first drug to be approved for the treatment of hyponatremia. This new therapeutic approach is targeted to restore sodium levels in hyponatremic patients. These patients are currently treated with fluid restriction, diuretics, and hypertonic saline, treatments that are often associated with inconsistent results and significant side effects.
Conivaptan has a unique aquaretic effect, resulting in increased excretion of free water by increasing urine output without increasing the sodium output. This effect may help normalize sodium levels in all patients with hyponatremia.
Hyponatremia is a common electrolyte disorder encountered in clinical medicine and is estimated to occur in approximately one percent to six percent of hospitalized patients in the United States. The majority of hyponatremia patients have congestive heart failure, but hyponatremia is also associated with syndrome of inappropriate anti-diuretic hormone (SIADH), liver cirrhosis, advanced renal failure, hypothyroidism, hepatic failure and chronic hypertension. Although hyponatremia patients are often asymptomatic, severe hyponatremia is considered a medical emergency that may lead to cerebral edema, respiratory arrest and possibly death.
"Conivaptan is the second product that Yamanouchi plans to introduce to the U.S. market," said Mr. Matsubara. "The FDA is also reviewing our investigational compound Vesicare® (solifenacin succinate) for the treatment of overactive bladder."
Yamanouchi Pharma America received an FDA approvable letter for Vesicare® (solifenacin succinate) in October 2003. In August 2003, the company signed an agreement with GlaxoSmithKline to co-promote the product in the United States. Also, a market authorization application for Vesicare® was submitted in Europe in January 2003 and Yamanouchi has initiated Phase III clinical trials in Japan.
Source: Yamanouchi Pharma America, Inc.