CSP No.1024 - A Phase III, Randomized, Multi-Center, Double Blind, Placebo-Controlled Study of Safety and Efficacy of Lofexidine for Relief of Symptoms in Subjects Undergoing Inpatient Opiate Detoxification.
Phase of Trial: Phase III
Latest Information Update: 27 Mar 2018
At a glance
- Drugs Lofexidine (Primary)
- Indications Opioid abuse
- Focus Therapeutic Use
- 27 Mar 2018 According to an US WorldMeds media release, the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine for mitigating opioid withdrawal symptoms. If approved, lofexidine will be marketed under the brand name LUCEMYRA™.
- 21 Nov 2017 According to an US WorldMeds media release,based on the data from this and other trial (see profile 239028), the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the New Drug Application (NDA) for lofexidine to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment. The Prescription Drug User Fee Act (PDUFA) date for lofexidine occurs during the second quarter of 2018.
- 20 Nov 2014 New trial record