Nektar presents NKTR-181 data showing 'consistently low abuse potential'
Nektar Therapeutics announced that new clinical and preclinical data for NKTR-181 were presented this week at the 80th Annual Scientific Meeting of the College on Problems of Drug Dependence in San Diego, California. NKTR-181 is 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. "We are privileged that these meaningful new data from our clinical trials, as well as our translational research, were recognized for oral presentation at the prestigious CPDD meeting," said Steve Doberstein, Ph.D., SVP and Chief Research and Development Officer of Nektar Therapeutics. "The data presented show that NKTR-181 demonstrates consistently low abuse potential when we look at a range of measurements used to understand potential abuse liability of investigational medicines including the MADDERS assessment. In addition, we demonstrated in our preclinical research that NKTR-181 has a unique neuropharmacodynamic profile with slow brain uptake and a blunted dopamine response as compared to oxycodone." Nektar recently submitted a New Drug Application for NKTR-181 for the treatment of chronic low back pain in adult patients new to opioid therapy. The NDA 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.