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Purdue Pharma Presents Considerations in Opioid Comparator Selection at the College on Problems of Drug Dependence Annual Scientific Meeting
Abuse-deterrent opioid formulations create barriers to certain routes and types of abuse by physical and chemical manipulation. The U.S. Food and Drug Administration (FDA) supports the development of opioids with abuse-deterrent properties as one potentially important step in helping to deter prescription opioid abuse and misuse.1 Opioids with abuse-deterrent properties won’t stop all prescription opioid abuse, but they are one part of a comprehensive multi-stakeholder approach to help address this complex public health issue. All opioids, including those with abuse-deterrent properties, expose users to the risks of addiction, abuse, and misuse.
The FDA has designated abuse-deterrent labeling for several extended-release opioids based on formulation and human abuse potential pre-market studies, not real-world studies. Since real-world data on opioid abuse can be affected by several factors, comparator drugs without ADFs are often used as reference in post-marketing epidemiological studies. Comparator opioids serve to reflect the secular trends in abuse over the study period. However, identifying comparators in post-marketing epidemiological studies may be difficult, given the multiple and varied ongoing initiatives intended to reduce prescription opioid abuse, as well as product formulations with distinct chemical and physical properties and individual characteristics of prescription opioids, such as availability, pharmacology, market use, and misclassification. The approach described in the poster includes important domains that should be considered when comparing and contrasting opioid products, and will better enable researchers in assessing the usefulness of individual comparators used in post-marketing studies.
Purdue is committed to addressing the opioid addiction crisis and has taken numerous actions to stem prescription opioid abuse in close collaboration with states, communities, industry partners, and law enforcement agencies. For additional information about Purdue’s commitment to addressing the opioid crisis, please read more about what we’re doing now.
About Purdue Pharma L.P.
Purdue Pharma and its subsidiaries develop and provide prescription medicines and consumer products that meet the evolving needs of healthcare professionals, patients, consumers and caregivers. We were founded by physicians and are currently led by a physician. Beyond our efforts to provide quality medications, Purdue Pharma is committed to supporting national, regional and local collaborations to drive innovations in patient care while also continuing our efforts to address the opioid addiction crisis.
Purdue’s subsidiaries include: Adlon Therapeutics L.P. focused on treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders; Avrio Health L.P. a consumer health products company that champions an improved quality of life for people in the United States through the reimagining of innovative product solutions; Imbrium Therapeutics L.P., established to further advance the emerging portfolio and develop the pipeline in the areas of CNS, non-opioid pain medicines, and select oncology through internal research, strategic collaborations and partnerships; and Greenfield Bioventures L.P. an investment vehicle focused on value-inflection in early stages of clinical development.
For more information, visit www.purduepharma.com.
1 S. Food and Drug Administration. Abuse-Deterrent Opioid Analgesics. 2018. Accessed June 5, 2019. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/abuse-deterrent-opioid-analgesics.