By Kim Coghill

Washington Editor

NitroMed Inc. received a letter from the FDA requesting a confirmatory study before BiDil can be approved as a therapeutic to extend the lives of African-American heart failure patients.

If approved, BiDil would be the first heart failure drug specifically indicated for use in blacks, said Michael Loberg, CEO of Bedford, Mass.-based NitroMed, a private company.

BiDil is a combination drug containing isosorbide dinitrate (ISDN) and hydralazine hydrochloride. In 1999, NitroMed acquired BiDil's NDA and related intellectual property from Jay Cohn, a professor at the University of Minnesota. NitroMed said BiDil was an opportunity to apply the company's nitric oxide-based expertise to a late-stage product with a clearly defined medical need.

BiDil was evaluated based on two vasodilator heart failure trials (V-HeFT I and II), large-scale clinical studies in heart failure patients. Published analysis from V-HeFT I and II showed that BiDil provides a selective benefit to black patients with heart failure as compared to non-black patients receiving the drug.

Data presented in both the BiDil NDA and recent published medical studies suggest that the racial disparities in mortality and therapeutic response rates in black heart failure patients may be due in part to ethnic differences in the underlying pathophysiology of heart failure.

Loberg said NitroMed has agreed to conduct a confirmatory clinical study to evaluate a composite of the quality of life, mortality and incidence of hospitalization in patients taking the drug vs. those on placebo. The trial is smaller than a pivotal trial and will consist of 600 patients with Class II/IV heart failure, he said. Loberg said NitroMed intends to continue studying BiDil for use in other patients.

He expects the confirmatory clinical study to begin during the second quarter and to take at least a year to complete. Upon completion and approval, Loberg expects that NitroMed will have the capability to market BiDil for this indication on its own.

Medical literature suggests that black patients are underserved by currently available heart failure medications. Statistically, black patients are twice as likely as white patients to suffer from heart failure. In addition, death rates from heart failure are more than twice as high in black patients than in white patients.

NitroMed develops and commercializes nitric oxide (NO)-enhanced medicines. By controlling the delivery of NO, a well-known mediator of biological function, NitroMed has developed a broad technology platform known as NitRx for delivering therapeutically active NO. NitroMed's current clinical areas of focus for its NO-enhanced medicines are based in the treatment and/or prevention of sexual dysfunction, inflammation, and cardiovascular and gastrointestinal disorders.

NitroMed is developing another product, NMI-870, for sexual dysfunction in men. Loberg said it is currently in Phase II trials in Europe and is being tested for drug interactions.