Posted by Michael Wonder on 31 Jul 2018
Nektar Therapeutics announces new drug application for NKTR-181 accepted for review by FDA
30 July 2018 - NKTR-181 is a first-in-class investigational opioid to treat chronic low back pain in adult patients new to opioid therapy.
Nektar Therapeutics today announced that the U.S. FDA has filed and accepted for review the company's new drug application for NKTR-181 for the treatment of chronic low back pain in adult patients new to opioid therapy. NKTR-181 is a new molecular entity and the first analgesic opioid molecule to exhibit a low incidence of specific CNS-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics.
The application is expected to be assigned a PDUFA target action date of 28 May 2019 by the FDA.
