Orexigen receives three month extension of FDA NB32 review Orexigen announced that the FDA has extended its review of the resubmitted New Drug Application for NB32, the company's investigational medication being evaluated for weight loss. The new Prescription Drug User Fee Act action date has been set for September 11. The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular outcomes for NB32. The NDA resubmission package includes interim safety and CV outcomes data from the ongoing 8,900 patient Light Study. Discussions around the package insert and other post-marketing obligations are ongoing.
Orexigen announces allowance of new U.S. patent for Contrave Orexigen Therapeutics announced that the company has received a notice of allowance from the U.S. Patent and Trademark Office for U.S. Patent Application No. 11/757,773, which covers use of Orexigen's sustained release formulation of naltrexone, which was designed to improve drug tolerability for Contrave in a method for treating obesity. The patent is expected to expire in March of 2028. Orexigen expects the patent to be listed in the Orange Book maintained by the FDA.