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12:00 AM
Jul 26, 2004
 |  BioCentury  |  Product Development

NitroMed: Patience pays off

NitroMed Inc. has waited almost six years for validation of its contention that BiDil, a nitric oxide-donating compound, would show benefit in African-American patients with heart failure. The company was prepared to wait even longer. But that won't be necessary, as last week NTMD halted its Phase III A-HeFT trial after a Data Safety and Monitoring Board (DSMB) and Steering Committee determined it would be unethical to continue the placebo-controlled study based on the significant survival benefit seen in the treatment group.

The data, in combination with new research associating nitric oxide deficiency with heart failure in African Americans, paint a different regulatory picture than in 2000, when NTMD sought approval of BiDil in this population.

BiDil is a combination of the generic drugs isosorbide dinitrate and hydralazine, neither of which is indicated for heart failure. However, each plays a potential role in vascular function. Isosorbide dinitrate, which has been approved to treat angina since 1959, is an NO donor. Hydralazine, which is approved for hypertension, is an antioxidant and vasodilator.

BiDil, which has been in development for more than 20 years, has had mixed clinical...

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