Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Nektar’s Opioid Analgesic Meets Endpoints in Phase III Clinical Trial


Nektar Therapeutics has announced that their opioid analgesic has met both its primary and secondary endpoint in a recent Phase III efficacy study.

Share this!

March 28, 2017 | by Sarah Hand, M.Sc.

The current opioid epidemic in the US has prompted pharmaceutical companies to develop alternative drugs with diminished abuse potential. Among these drugmakers is Nektar Therapeutics, who has announced that their opioid analgesic has met both its primary and secondary endpoint in a recent Phase III efficacy study.

The drug, referred to as NKTR-181, is a first-in-class full mu-opioid agonist molecule. According to Nektar, the drug provides relief for chronic pain without causing a sense of euphoria; it’s this euphoric high that often leads to opioid abuse and addiction.

“The data from this efficacy study are extremely important because they demonstrate that NKTR-181 produces strong analgesia in patients suffering from chronic pain while NKTR-181 has also demonstrated significantly lower abuse potential than oxycodone in a human abuse potential study,” said Dr. Martin Hale, clinical investigator and medical director of Gold Coast Research. “While standard opioid analgesics, including abuse-deterrent formulations, have been the most effective way to treat chronic pain, they are associated with serious safety concerns and many opioid-naïve patients fear taking them because of the potential for abuse and addiction. The data for NKTR-181 suggest that it is a transformational pain medicine that could fundamentally change how we treat patients with chronic pain conditions.”

The Phase III clinical trial – dubbed, SUMMIT-07 – investigated the efficacy of twice-daily dosing of NKTR-181 in over 600 patients with chronic low back pain. These patients categorized their pain as either moderate or severe, and none of the participants in this study had ever used opioid drugs before.

The drug met its primary endpoint of significantly improving back pain over the placebo. Secondary endpoints were also met, which included statistically significant reduction in pain in a proportion of study participants.

Low back pain is a common cause of disability in the US, which is responsible for an estimated $100 to 200 billion in lost wages, lower productivity and other costs. It’s estimated that 19 percent of the US population suffers from chronic pain, according to a 2014 study published in the American Pain Society's The Journal of Pain.

Keywords: Opioid, Clinical Trial, Painkiller


Share this with your colleagues!

Canadian Regulator Recalls Pie Shells Over E. Coli Contaminated Flour

April 28, 2017 - Multiple brands of pie and tart shells are being recalled in Canada after the flour used to manufacture them was linked to 28 cases of illness due to infection with E. coli O121.

Featured In: Food News

FDA Sends Warning Letters to Manufacturers of Fake Cancer Drugs

April 27, 2017 - The FDA is cracking down on the sale of illegal cancer drugs by sending warning letters to 14 US companies selling the unapproved products.

Featured In: Life Science News, Drug Safety News

Womb-Like Device Could Increase Survival of Premature Babies

April 27, 2017 - Researchers at the Children's Hospital of Philadelphia (CHOP) have developed a womb-like device which mimics the environmental conditions found inside the uterus.

Featured In: Life Science News, Medical Device News


What Medical Device Manufacturers Need to Know Before Developing a Biological Safety Evaluation


Technology Solutions for Late Phase Research: Optimising Real World Data Assets

Serialization for Late Starters – With Live Industry Research Results

Clinical Not All Antioxidants Are Created Equal: Astaxanthin, The Antioxidant Powerhouse

The New Gold Standards of IRT Delivery for Clinical Trials

Copyright © 2016-2017 Honeycomb Worldwide Inc.