FDA pushes PDUFA for Nektar opioid analgesic

Nektar Therapeutics Inc. (NASDAQ:NKTR) said late Thursday that FDA has extended by three months its review of an NDA for NKTR-181 to treat chronic low back pain in adults new to opioid therapy. NKTR-181's new PDUFA data is Aug. 29.

Nektar said the extension will give FDA time to review preclinical data from two additional studies that the agency had requested. The company said the new data support its abuse liability package for NKTR-181...