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Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence
Date:6/19/2013

nts with chronic pain."

Additional Study Results

  • Assessment of "Feeling High"
  • All oral doses of NKTR-181 scored similar to placebo in a Drug Effects Questionnaire (DEQ) assessing the treatment's effect on how "high" the subject felt (on a scale of 0 (not at all) to 100 (extremely)).  Oxycodone oral solution resulted in a maximum mean DEQ score of 81.
    NKTR-181 maximum mean DEQ scores were 14, 14 and 23 for 100 mg, 200 mg tablet and 400 mg, respectively, with p-values < 0.0001 as compared to oxycodone.  Placebo achieved a maximum mean DEQ score of 9. 

  • Assessment of "Sleepiness"
  • Sedation was measured using a DEQ assessment of sleepiness (on a scale of 0 (not at all) to 100 (extremely).  All doses of NKTR-181 scored lower on sleepiness when compared to oxycodone.  The maximum mean DEQ sleepiness score for oxycodone was 44 as compared to the maximum mean DEQ scores for NKTR-181 100 mg, 200 mg and 400 mg of 10, 9, and 18, respectively (p<0.0001). 

    Study DesignThe randomized, double-blind, placebo- and active-controlled, 5-way crossover trial, compared the effects of three doses of NKTR-181 oral solution (100 mg, 200 mg, and 400 mg), to the effects of 40 mg of oxycodone oral solution and placebo.  Participants were healthy adults (N=42) who were not currently physically opioid-dependent but had used opioids to attain non-medical effects on at least 10 occasions during the past year and at least once in the 12 weeks before the study.  Study participants sequentially received the five treatments, administered in a randomized, double-blinded fashion, with each treatment separated by a washout period.  The study also utilized a Williams Square cross-over design, which uses a series of randomized sequences for each individual subject.

    About NKTR-181 NKTR-181 is currently being evaluated in Phase 2 development as a twice-daily oral tablet to treat chronic
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    SOURCE Nektar Therapeutics
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