Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB) (BEAD-MB)

Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond ER (BEAD-MB) (PMR 2961-9)

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.

Study Overview

• Status: Completed
• Conditions: Baseline Epidemiologic Assessment
• Intervention / Treatment: Drug: MorphaBond ER; Drug: Comparator Drug

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 17566

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Daiichi Sankyo, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MorphaBond ER users and relevant comparator users

Description

Inclusion Criteria:

• Male or female
• MorphaBond ER users or relevant comparator users

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MorphaBond ER	Drug: MorphaBond ER; This was a retrospective, non-interventional study. Previous users of branded and generic products (tablets or capsules) with ER and immediate release (IR) release type formulations of oxycodone, oxymorphone, hydromorphone and morphine (except MorphaBond).
Comparator Group	Drug: Comparator Drug; This was a retrospective, non-interventional study. Previous users of the MorphaBond ER brand of ER morphine sulfate with A-D labeling, by prescription or non-prescription.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed	October 2017 through September 2020
Percentage and rates of abuse/abuse-related outcomes of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020
Rates of misuse of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020
Rates of addiction of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020
Overdose rates of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020
Overall mortality rates and opioid overdose death rates of MorphaBond Extended Release (ER) vs. comparators	October 2017 through September 2020

Secondary Outcome Measures

Outcome Measure	Time Frame
Number and proportion of abuse-related outcomes by routes of administration (e.g. ingestion, inhalation, etc).	October 2017 through September 2020

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Investigators: Study Director: Safety Study Director, Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Abuse; Overdose; Misuse
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: MORPH-A-U403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No