June 11 Orexigen Therapeutics Inc said the U.S. Food and Drug Administration delayed its decision on the marketing application of its obesity drug, contrave, by three months, sending its shares down about 12 percent in premarket trading.
The regulator, which rejected the drug in 2011, indicated the extension is associated with potential post-marketing obligations and set Sept. 11 as its new date for review.
The FDA had asked the company to conduct additional trials on the drug, citing potential heart risks.
An interim analysis of the latest 8,900-patient study showed that overweight and obese patients receiving contrave did not have a higher heart risk, compared with those on a placebo, the company said in November. (Reporting by Natalie Grover in Bangalore; Editing by Don Sebastian)