Manufactured by Nektar Therapeutics, NKTR-181 is designed to have a slow rate of entry into the brain to reduce side effects from the central nervous system, such as sedation and respiratory depression, said Nektar Therapeutics Chief Medical Officer Robert Medve, MD. The company requested fast track designation from the FDA based upon promising safety and effectiveness results from preclinical and Phase 1 clinical studies.
NKTR-181 is next slated for a Phase 2 development program that will use a randomized, placebo-controlled design to evaluate the drug's effectiveness in up to 200 patients with chronic pain from osteoarthritis of the knee.
With a fast track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which could decrease the typical development time and review period.
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