Chronic Low Back Pain ( Moderate to Severe )

Description

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.

http://www.nektar.com/product_pipeline/cns_pain_nktr-181.html

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.

Details