Posted by Michael Wonder on 01 Jun 2018
Nektar Therapeutics announces submission of a new drug application to the U.S. FDA for NKTR-181, a first-in-class investigational opioid to treat chronic low back pain in adult patients new to opioid therapy
31 May 2018 - Nektar Therapeutics today announced submission of a new drug application to the U.S. FDA for NKTR-181, a new molecular entity and the first analgesic opioid molecule to exhibit a reduced incidence of specific CNS-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics.
The application is supported by an extensive clinical and nonclinical data package. The clinical data submitted in the application comprised 15 studies in 2,234 subjects and includes: a 600-patient efficacy study in patients with chronic low back pain who are new to opioid therapy; a 630-patient long-term 52-week safety study in patients with non-cancer pain, who are new to opioid therapy, as well as those who are experienced with opioid therapy; pharmacokinetic/pharmacodynamic studies in over 450 subjects; and two human abuse potential studies evaluating both therapeutic and supra-therapeutic doses of NKTR-181 versus an oxycodone control in recreational drug users.
