FREMONT, Calif., June 1 (UPI) -- Scios said Thursday it was launching a major study to assess the safety profile of its heart-failure drug Natrecor.
The announcement comes on the heels of a Wall Street Journal article this week about critics questioning why Johnson & Johnson, Scios' parent company, has delayed initiating the study for more than a year after it was recommended by a panel of experts.
Natrecor came under fire last year after two studies in medical journals suggested the drug may increase the risk of kidney failure and death.
Scios said that since the panel issued its recommendations the company "has been actively exploring a broad range of trial design options that would meet the goals identified by the panel, as well as other critical goals to further advance knowledge of heart failure."
The trial, which is slated to begin enrolling patients in the first quarter of 2007, will involve as many as 7,000 patients and will evaluate shortness of breath, re-hospitalization, mortality, renal effects, quality of life and pharmacoeconomics.
"This trial underscores our confidence in the safety and efficacy of Natrecor," said Roger Mills, Scios' vice president of medical affairs.
