> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Nektar NDA for Pain Drug Accepted for Review
- URL: https://www.fdaweb.com/nektar-nda-for-pain-drug-accepted-for-review/
- Published: 2018-07-30T12:00:00.000Z
- Updated: 2026-09-15T00:22:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142000

FDA has accepted for review a Nektar Therapeutics NDA for NKTR-181 for treating chronic low back pain in adult patients new to opioid therapy. The new molecular entity is the first analgesic opioid molecule to exhibit a low incidence of specific central nervous system-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics, the company says. The NDA is expected to be given a user fee review action target date of 5/28/2019.

  
Nektar’s submission is supported by clinical data from 15 studies in 2,234 subjects. It includes a “600-patient efficacy study in patients with chronic low back pain who are new to opioid therapy; a 630-patient long-term 52-week safety study in patients with noncancer pain, who are new to opioid therapy, as well as those who are experienced with opioid therapy; pharmacokinetic/pharmacodynamic studies in over 450 subjects; and two human abuse potential studies evaluating both therapeutic and supratherapeutic doses of NKTR-181 versus an oxycodone control in recreational drug users,” the company says.