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
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