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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

ain is important in abuse.  When we look at the critical period following dosing when the commonly abused drug oxycodone reaches maximum liking, NKTR-181 was not distinguished from placebo with respect to both drug-liking and feeling high.  These are two of the most important metrics that help us understand the abuse potential of a medicine.  Importantly, NKTR-181 was dosed as an oral liquid, which underscores that its less rewarding properties are inherent to this NCE and independent of any abuse-deterrent formulation.  These data, along with previous efficacy data, suggest NKTR-181 may be a major advance towards safer opioid therapy for the treatment of moderate to severe chronic pain."

The HAL study compared drug liking between each treatment group (oxycodone 40 mg, Placebo, and NKTR-181 100 mg, 200 mg, and 400 mg).  On the bipolar VAS scale (0-100), a score of 50 indicates that the subject "neither likes nor dislikes" the drug.  In the study, 40 mg of oxycodone oral solution resulted in a maximum mean drug liking score of 85, indicating a "strong liking" for the effects of oxycodone.  The oxycodone liking score was significantly different from placebo as early as 15 minutes after dosing and peaked at 60 minutes. In the placebo arm, the maximum mean drug liking score was 50, indicating that the subjects neither liked nor disliked the effects.  NKTR-181 dosing was similar to placebo with maximum mean drug liking VAS scores of 58, 58 and 63 for 100 mg, 200 mg and 400 mg, respectively.

"The data from this study are remarkable and clearly demonstrate that drug abusers could not discriminate NKTR-181 from placebo at doses that we know produced analgesia in the validated pain models from our Phase 1 studies," said Robert Medve MD, SVP and Chief Medical Officer of Nektar Therapeutics. "These data suggest that NKTR-181 could change the way we think about opioids and how we treat patie
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SOURCE Nektar Therapeutics
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