An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients with Opioid Use Disorder
Phase of Trial: Phase III
Latest Information Update: 15 Feb 2018
At a glance
- Drugs Buprenorphine (Primary)
- Indications Opioid abuse
- Focus Adverse reactions; Registrational
- Sponsors Braeburn Pharmaceuticals
- 15 Feb 2018 According to a Camurus media release, An opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use is expected in Q3 2018, and final approval decisions from both the EMA are anticipated in Q4 2018.
- 21 Jan 2018 According to a Braeburn Pharmaceuticals media release, the company has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for CAM2038, the FDA has requested additional information in order to progress the application forward.
- 01 Nov 2017 According to a Camurus media release, the US Food and Drug Administrations (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History