Trial Profile
A Phase 3, Randomized, Double Blind, Multiple Dose, Parallel Group, Placebo Controlled Study of Buprenorphine Sublingual Spray (0.5 mg TID, 0.25 mg TID, and 0.125 mg TID) for the Treatment of Moderate to Severe Pain
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 16 Jan 2020
Price :
$35
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At a glance
- Drugs Buprenorphine (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors INSYS Therapeutics, Inc
Most Recent Events
- 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.
- 06 Dec 2017 According to an INSYS Therapeutics, Inc media release, a New Drug Application (NDA) for buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain has been accepted for filing by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of July 28, 2018 to complete its review of this NDA. The application was based on this study and several pharmacokinetics studies.