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# FDA Rejects INSYS NDA for Pain Spray
- URL: https://www.fdaweb.com/fda-rejects-insys-nda-for-pain-spray/
- Published: 2018-07-27T12:00:00.000Z
- Updated: 2026-09-15T00:22:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141978

FDA has issued INSYS Therapeutics a complete response letter for its buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain. The letter adheres to an advisory committee vote in May and “indicates that, although the clinical development program demonstrated all three proposed doses of the product candidate were statistically significantly different than placebo in providing pain relief, some of the data suggested potential safety concerns,” the company says. “Given the attributes of our proprietary buprenorphine formulation for sublingual delivery, we continue to believe that this drug-device combination could bring value to the management of pain and will assess the next steps in the context of the company's overall mission.”  
  
The submission was based primarily on a pivotal trial that met its primary efficacy endpoint and several pharmacokinetics studies, according to INSYS. It says that the potential benefits of buprenorphine include a “ceiling effect for respiratory depression and, compared to other opioids frequently used in this indication, less abuse potential, less cognitive impairment and less constipation.”