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Nektar Announces Start of Enrollment in Phase 2 Study of NKTR-181, a Novel Opioid Analgesic Molecule, for Treatment of Chronic Pain
Date:7/24/2012

mon method that has been used with opioid drugs in order to attempt to block their conversion into abusable forms of an opioid. Phase 1 studies demonstrated that NKTR-181 produced sustained and dose-dependent analgesic responses in healthy volunteers, a slower rate of CNS entry as measured by pupillometry, or contraction of the pupils, and an excellent tolerability profile. NKTR-181's Phase 1 clinical development program evaluated the molecule in approximately 180 healthy volunteers. 

"As a new mu-opioid analgesic molecule, NKTR-181 has the potential to transform the treatment of chronic pain by using a molecular approach to reduce the risk of traditional opioid therapy while preserving its analgesic benefit," said Robert Medve, MD, the company's Senior Vice President and Chief Medical Officer. "We are excited to be advancing this molecule into Phase 2 testing in chronic pain patients."

The NKTR-181 Phase 2 study uses a randomized withdrawal design, which includes a baseline period and a drug titration period followed by a randomized, placebo-controlled, double-blind phase of the study. The primary endpoint of the study will be the average change in a patient's pain score from baseline to the end of the double-blind, randomized treatment period. The study will enroll opioid-naive patients with osteoarthritis of the knee who are not getting adequate pain relief from their current non-opioid pain medication. Patients who qualify during the baseline period will enter a titration phase, during which they will be titrated on NKTR-181 tablets administered orally twice-daily until a dose is reached that provides a reduction of at least 20% in the patient's pain score as compared to the patient's own baseline. Patients that achieve this level of analgesia will then be randomized on a 1:1 basis to either continue to receive their analgesic dose of NKTR-181 or to receive placebo for up to 25 days. Secondary endpoints of the st
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SOURCE Nektar Therapeutics
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