New Data for NKTR-181

New Data for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy, Presented at College on Problems of Drug Dependence 80th Annual Scientific Meeting…

Nektar Therapeutics (NKTR) today 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 (CPDD) in San Diego, California. NKTR-181 is a new molecular entity (NME) 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., Senior Vice President 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.”


Still got skin in the game with NKTR


And here is a direct link to the slide deck for the presentation:…

By my estimation, NKTR did its due diligence following established study guidelines (MADDERS - Misuse, Abuse, and Diversion Drug Event Reporting System) to address abuse potential. Their conclusions are as follows:

• No discernible difference was detected in responses between NKTR-181 and placebo treated groups
• Very few (~ 5% per group) subjects reported taking more medication than instructed either unintentionally (Therapeutic Error) or intentionally (Misuse) for a therapeutic purpose
• Withdrawal symptoms were reported by 7 (2.9%) and 5 (2.1%) subjects in the NKTR-181 and placebo groups, respectively
• No subjects acknowledged abusing the drug, being addicted to it, changing the route of administration or using it to attempt suicide
– This is common for self-reported survey instruments
– The main role of this survey is to complement the primary
event-driven approach of MADDERS
– Values are based on subjects completing Medication Use Survey (N = 243 for NKTR-181 and N = 236 for placebo)

Estimated 17.7 billion TAM of US opioid market:…

181 FDA approval is near term catalyst to support/advance NKTR shares.

Increasing long NKTR,