Nektar Phase II Trial for NKTR-181 Misses Primary Endpoint


Announces Preliminary Topline Results from 2 Efficacy Study for NKTR-181 in Chronic Pain Patients with Osteoarthritis of the Knee

Company to Host Conference Call on Thursday, September 26th at 1:30 PM Pacific Time/4:30 PM Eastern Time to Discuss Results

SAN FRANCISCO, Sept. 26, 2013 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR) announced the preliminary topline results from a Phase 2 study of NKTR-181 for the treatment of moderate-to-severe chronic pain in patients with osteoarthritis of the knee. The Phase 2 study utilized a double-blind, placebo-controlled, randomized withdrawal study design to assess the efficacy, safety and tolerability of NKTR-181. Of the 295 patients that entered the study, only 9 (3%) patients were unable to achieve meaningful pain relief with NKTR-181.  53 (18%) patients discontinued treatment during the titration period because of adverse events, most of which are those commonly associated with opioids.  A total of 213 patients achieved an average 40% reduction in pain and entered the randomized phase of the study.

Following the titration period, patients were randomized 1:1 to either continue to receive their analgesic dose of NKTR-181 or to receive placebo for 21 days.  NKTR-181 performed as expected as an opioid analgesic throughout the study with patients continuing to show a reduction in pain scores throughout the randomized phase of the study as well.  However, patients who were randomized to placebo did not show the expected increase in pain scores observed in similar enriched enrollment, randomized withdrawal studies.  This unusual lack of a placebo rebound caused the Phase 2 study to miss the in the study, which was based upon the average change in a patient’s pain score from pre-randomization baseline to the end of the double-blind, randomized treatment period of the study.

“We are experiencing a major public health problem with prescription opioids in this…Read more

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