US FDA Panel Gives Nod To Neurex' Corlopam

US firm Neurex Corp's Corlopam (fenoldopam) has received a Food and DrugAdministration advisory committee recommendation for approval as an intravenous therapy for the short-term treatment of hypertension when oral therapy is not feasible or possible, including use in patients who are undergoing surgery or who, for other reasons, cannot take oral medication. Also recommended for approval was the treatment of severe or malignant hypertension.

The panel's decision is said to be based on a review of data in over 1,000 patients, including three studies conducted by Neurex following the licensing of fenoldopam - a potent dopamine (D1) receptor antagonist - from SmithKline Beecham in 1994. These demonstrated that treatment with Corlopam resulted in predictable and prompt reduction in blood pressure for patients who need acute intervention in the hospital setting.

Most panel members said additional studies were needed to determine the effects on patients who might use both Corlopam and beta blockers; they also suggested a simple label warning about using beta blockers. Analysts expect sales of the drug will exceed $40 million by 2000. It is already approved in Italy, Belgium and the Netherlands. Despite the recommendation, Neurex' share price fell 15.3% to $2.625.