Resubmission expected for Orexigen's obesity drug Contrave

29 August 2013

US biopharma company Orexigen Therapeutics (Nasdaq: OREX) has announced that the Light Study independent Data Monitoring Committee (DMC) has recently confirmed that sufficient major adverse cardiovascular events (MACE) are expected to occur within the next two months, meaning that interim analysis will be conducted by early December. After the announcement Orexigen shares dropped 7.46% and closed at $6.70.

Obesity drug Contrave (naltrexone SR/bupropion SR) has been previously rejected by the US Food and Drug Administration ( The Pharma Letter, February 2, 2011) and the European Medicines Agency due to cardiovascular concerns.

Evidence collected by the Light Study will mean the New Drug Application could be resubmitted to the US FDA by the end of the year. The DMC also recommended that the Light Study continue as planned with no changes to the protocol.

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