Empatic regulatory update
Orexigen disclosed in its 4Q12 earnings that FDA said Phase III data for obesity candidate Empatic may be sufficient to support an NDA submission without data from a cardiovascular outcomes trial. According to the company, the agency indicated that as long as the placebo-subtracted changes in body weight, blood pressure and heart rate for Empatic are similar to or more favorable than those observed with Contrave - and that there are no signals of cardiovascular concern in the Empatic development program - reassuring results of a CV outcomes trial with Contrave will be sufficient. Contrave, the company's lead obesity candidate, is being evaluated in a CV outcomes trial - the Phase III Light Study. Contrave is a fixed-dose combination of naltrexone HCL sustained release (SR) and bupropion HCL SR (see BioCentury, Jan. 14). ...