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Nektar Posts Positive Topline Data From Human Abuse Potential Study For NKTR-181

Nektar Therapeutics (NKTR) announced Tuesday positive topline results from an oral Human Abuse Potential or HAP study of NKTR-181, a first-in-class opioid analgesic. The company noted that NKTR-181 shows significantly less abuse potential compared to oxycodone.

NKTR-181 is a new chemical entity or NCE that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids.

The company noted that NKTR-181 is the first analgesic opioid molecule to exhibit reduction in specific CNS-mediated side effects, like euphoria, through the strategic alteration of brain-entry kinetics. The U.S. Food and Drug Administration has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.

Nektar said the NKTR-181 HAP study was designed to confirm and assess the relative oral abuse potential of NKTR-181 at its maximum analgesic or therapeutic dose of 400 mg and at a supratherapeutic dose compared to common therapeutic doses of a Schedule II opioid, oxycodone.

HAP studies are clinical studies that help assess the relative abuse potential of a medicine. The NKTR-181 HAP study was a randomized, double-blind, placebo-controlled, six-sequence crossover study. It evaluated the relative oral abuse potential of NKTR-181 relative to the Schedule II opioid oxycodone in healthy non-dependent recreational drug users experienced in the oral abuse of opioids who can identify drug effects that are relevant to abuse risk assessment.

by RTT Staff Writer

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