Nektar Therapeutics announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review the company’s New Drug Application (NDA) 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 (NME) 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 NDA is expected to be assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 28, 2019 by the FDA.
Nektar’s NDA submission is supported by an extensive clinical and nonclinical data package. The clinical data submitted in the NDA 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 noncancer 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 supratherapeutic doses of NKTR-181 versus an oxycodone control in recreational drug users.
NKTR-181 is an investigational medicine and has not been approved by the FDA or any other regulatory agencies. While the NDA submission for NKTR-181 has been accepted for review by the FDA, such acceptance does not mean that NKTR-181 will be approved by the FDA.