Scios Inc. announced on Thursday that it would spend more than $100 million to conduct a safety and effectiveness study of its controversial heart failure drug, Natrecor.
The trial is designed to address safety issues swirling around the drug since last year when other studies suggested Natrecor can lead to increased risk of kidney problems and a higher risk of mortality within the first month of treatment than traditional medicines. Patient enrollment is slated to begin in the first quarter of next year and will involve 7,000 people in the United States, Canada and Europe, Scios said.
Scios, a division of Johnson & Johnson, still has to select the lead researchers for the study. The company doesn’t know how long the trial will take to complete.
Natrecor, an intravenous drug approved in 2001, is designed to treat the breathing problems
Natrecor, an intravenous drug approved in 2001, is designed to treat the breathing problems that often accompany heart failure. Some experts had expressed concern about the drug being used in an outpatient setting instead of only the hospital. J&J received a subpoena from the U.S. Attorney’s Office in Boston last year requesting information about the marketing of Natrecor.
Last year, the U.S. Food and Drug Administration told Scios to add more information about the risk of death from Natrecor on the package insert for doctors.
Scios convened a panel of experts to provide recommendations about Natrecor in the wake of the negative publicity. The panel, organized last June, endorsed Scios’ plan to conduct several trials of the drug.
Dr. Roger Mills, Scios’ vice president for medical affairs, said it has taken a year to announce the study because the company wanted to insure it was appropriately designed and answered all the questions raised.
J&J doesn’t break out Natrecor’s sales but Scios spokesman Chris Ernst said its revenue has fallen since last spring when the safety concerns emerged.