Human Abuse Potential of Oral NKTR-181 in Recreational Opioid Users: A Randomized, Double-Blind, Crossover Study.

In SUMMIT-07, a phase 3 double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal trial of 610 subjects, which included a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS) assessment, NKTR-181 administered at 100–400 mg every 12 hours was associated with a highly significant analgesic effect compared with placebo throughout 12 weeks of treatment in patients with moderate to severe chronic low back pain (CLBP), with a low incidence of CNS adverse events and a favorable safety profile [ 31 , 32 ].

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