Nektar Therapeutics announced that the FDA has designated NKTR-181 as a Fast Track development program for the treatment of moderate to severe chronic pain.
Nektar requested Fast Track designation from the FDA for NKTR-181 based upon what is known about its safety and efficacy profile to-date from both preclinical and Phase 1 clinical studies, as well as NKTR-181’s potential to treat chronic pain conditions with an improved safety profile over existing therapies. NKTR-181 has completed a Phase 1 clinical development program, which evaluated its pharmacokinetics, pharmacodynamics and safety. Phase 2 development will use a standard, randomized, placebo-controlled withdrawal study to evaluate the efficacy and safety as well as a human abuse liability study.
NKTR-181 is a mu-opioid agonist molecule, which is designed to have a slow rate of entry into the brain to reduce the attractiveness of the molecule as a target of abuse. Its novel mechanism of action also reduces its CNS-mediated side effects.
For more information call (855) 482- 6587 or visit www.nektar.com.