Chronic Low Back Pain ( Moderate to Severe )

    Not Recruiting
  • sponsor
Updated on 23 November 2020


Chronic Low Back Pain ( Moderate to Severe )


SUMMIT Phase 3 Program
The SUMMIT Phase 3 program for NKTR-181 includes two enriched-enrollment, randomized withdrawal (EERW) efficacy and safety studies and a 52-week long-term safety study (SUMMIT-LTS). Enrollment has begun in the first Phase 3 efficacy study (SUMMIT-07) which will evaluate NKTR-181 versus placebo in opioid-naïve patients with chronic low back pain.

NKTR-181 is a new chemical entity (NCE) that was created using Nektar's proprietary small molecule polymer conjugate technology. NKTR-181 has several potential differentiating properties that are inherent to the structure of the molecule, including a slow rate of entry into the CNS as measured by pupillometry (contraction of the pupils) and a plasma pharmacokinetic profile that supports twice-daily oral dosing. NKTR-181 is not a reformulation of a marketed opioid, which is a commonly-used method to attempt to prevent the manipulation of existing long-acting opioid drugs into more abusable forms. NKTR-181 has been granted has been granted Fast Track designation for the treatment of moderate to severe chronic pain by the U.S. Food and Drug Administration.

Participation in this research study could last up to 25 weeks. At the end of the study, there may be the opportunity to enroll into an open-label, long-term safety study of NKTR-181. "Open Label" means that everyone in the long-term safety study will be receiving NKTR-181.

Condition Chronic Back Pain, Back Pain, Chronic Pain
Clinical Study IdentifierTX140792
Last Modified on23 November 2020

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