Drug Safety Information for BELBUCA ()

REMS for Belbuca (BUPRENORPHINE HYDROCHLORIDE) Rx Drug: Safety Information Link

Shared FDA Risk Evaluation and Mitigation Strategy

FDA Safety-related Labeling Changes for BELBUCA (BUPRENORPHINE HYDROCHLORIDE) Rx Drug: Safety Information Link

Required post-approval safety study:

A prospective, observational study designed to quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed ER/LA opioid analgesics. This study must address at a minimum the following specific objectives: a. Estimate the incidence of misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain. Examine the effect of product/formulation, dose and duration of opioid use, prescriber specialty, indication, and other clinical factors (e.g., concomitant psychotropic medications, personal or family history of substance abuse, history of psychiatric illness) on the risk of misuse, abuse, and addiction. b. Evaluate and quantify other risk factors for misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain, including but not limited to the following: demographic factors, psychosocial/behavioral factors, medical factors, and genetic factors. Identify confounders and effect modifiers of individual risk factor/outcome relationships. Due Date: 2020-03-31

Original FDA Drug Approval Date for BELBUCA: 2015-10-23

FDA Adverse Event Summary for BELBUCA (not avail) Unavailable