A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain
Phase of Trial: Phase II
Latest Information Update: 27 Jul 2018
At a glance
- Drugs Buprenorphine (Primary) ; Morphine; Oxycodone
- Indications Postoperative pain
- Focus Adverse reactions
- Sponsors INSYS Therapeutics, Inc
- 27 Jul 2018 According to an INSYS Therapeutics media release, the FDA has issued a Complete Response Letter (CRL) regarding the NDA for buprenorphine sublingual spray. The CRL 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.
- 22 May 2018 According to an INSYS Therapeutics, Inc media release, company confirmed that an expert panel convened by the U.S. Food and Drug Administration (FDA) voted not to recommend approval of the company's New Drug Application (NDA) for a buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.
- 02 Jan 2018 Planned End Date changed from 28 Dec 2017 to 28 Jan 2018.