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

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.