Braeburn dealt setback over monthly, weekly opioid abuse therapy

The FDA has issued a complete response letter to Braeburn Pharmaceuticals, denying its application for an investigational weekly and monthly buprenorphine depot injection designed to treat adults with opioid use disorder.
The company reported that the dreaded CRL does not request additional clinical studies, but Braeburn did not elaborate as to what sort of additional information the FDA needs to move the application forward.
Get the full story at our sister site, Drug Delivery Business News.
The post Braeburn dealt setback over monthly, weekly opioid abuse therapy appeared first on MassDevice.

Source: Mass Device - January 22, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pain Management Pharmaceuticals Regulatory/Compliance Braeburn Pharmaceuticals Source Type: news