Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
The main objectives of this study are to provide surveillance/descriptive data to (a) assess
 utilization of MorphaBond ER and selected comparators overall and by age group and census
 regions using nationally-projected quarterly drug dispensing data and (b) assess the scope
 and pattern of abuse and clinical outcomes for MorphaBond ER using nationally representative
 data or data from large geographic areas in different populations.

 Findings of this study will support the design of formal epidemiology assessment of the risks
 of addiction, overdose, and death outcomes associated with MorphaBond ER and appropriate
 comparators in the future.
The study started after the launch of MorphaBond ER in October 2017 and will continue until
 September 2020 and the final study report will be submitted to the FDA by December 2020.

 This is an observational study that will provide descriptive data on the utilization and
 abuse of MorphaBond ER and related outcomes (addiction, misuse, abuse, overdose,
 overdose-related deaths) for MorphaBond ER and selected comparators in response to the
 US-FDA's post-marketing requirement (PMR 2961-9 for MorphaBond ER).

 No investigational products or pharmaceutical agents will be provided or administered for the
 purpose of this study. Multiple data sources, representing different populations and large
 geographic areas in the US, will be utilized to study the patterns of MorphaBond ER
 utilization and abuse and related outcomes.

 The overall purpose of this study is to collect meaningful baseline data to support
 subsequent studies for formal epidemiologic assessment of abuse deterrence of MorphaBond ER
 as required by the FDA.
Inclusion Criteria:

 -  Male or female

 -  MorphaBond ER users or relevant comparator users

 Exclusion Criteria:

 -  Not applicable