NB32 may need second CV outcomes trial

Orexigen Therapeutics Inc. (NASDAQ:OREX) fell $1 (15%) to $5.81 on Wednesday after the company made comments during a conference call that suggest FDA may require a separate study postapproval to evaluate cardiovascular outcomes for NB32 naltrexone/bupropion. The call was held to discuss a three-month extension of the PDUFA date for a resubmitted NDA for NB32, which is under review to manage obesity, including weight loss and the maintenance of weight loss. The new PDUFA date is Sept. 11; it was June 11.

According to Orexigen, FDA needs time to reach agreement on the postmarketing obligation related to the previously agreed-upon evaluation of CV outcomes for the product, including issues related to data transparency and disclosure. The company said it plans to use data from the ongoing Phase III Light Study to fulfill the postmarketing requirement, but noted on the conference call that for some recent diabetes drugs, companies have unblinded ongoing trials after the interim analysis and conducted a new trial for the postmarketing requirement. Orexigen declined to confirm whether a separate postapproval CV study for NB32 may be required, but said roughly 75% of postapproval development would be funded by partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), which has North American commercialization rights to NB32. ...