We recently spoke with Dr. Simon Budman, an internationally known researcher and innovator, on his thoughts about the challenges around opioid abuse including the significance of routes of administration and the role of generics in the marketplace.
Q1: Dr. Budman, what’s the significance of abusers using alternative routes of administration?
A: It’s essential to examine routes of administration (RoA). Truly effective abuse deterrent drugs require formulations that prevent alternative RoAs (snorting, chewing, injecting, smoking). There are currently no abuse deterrent formulations that prevent abuse by a traditional swallowing method and the holy grail in abuse deterrence is a product that prevents users from taking too many/too much of a drug. The FDA is interested in dropping the overall rate of abuse but also in formulations that prevent as many alternative RoA’s as possible.
Q2: What public health impact can a better understanding of RoAs have?
A: We have data that indicates that abusers who use alternative ROAs are more likely to have more significant impairment in other life domains (medical, legal, family, employment, and mental health). It’s important to really understand how these alternative routes affect overall functioning in order to effectively prevent and treat opioid abuse.
Q3: How do generics play into the abuse deterrence equation?
A: As long as there are generics available that are not in an ADF formulation and allow a variety of alternative routes, it’s almost impossible for branded ADFs to significantly affect the abuse epidemic. There’s nothing to prevent an abuser from choosing a non-abuse deterrent generic over a branded ADF. It’s important to note that ADFs currently cover only about 5% of the market. New draft guidance from the FDA suggests an intention to move generics to ADFs as well, although this is still in development.
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About: Dr. Simon Budman, an internationally known researcher and innovator, founded Inflexxion in 1989. Prior to launching Inflexxion, Dr. Budman served as the director of mental health research at Harvard Community Health Plan and associate director of the Institute for Health Research at the Harvard School of Public Health. He earned his Ph.D. at the University of Pittsburgh and was trained as a clinical psychologist. He completed his internship training at Yale Medical School and post-doctoral training at the University of Rochester Medical School. Dr. Budman has authored over 100 publications on behavioral health care, substance abuse and technology topics. In 2000 Dr. Budman received two highly prestigious national awards. From the American Psychological Association (APA) he received their Distinguished Contributions to Knowledge Award and from the Dorothy and Nicholas Cummings Foundation the $50,000 Psyche Award to the behavioral health professional who is deemed to have made the greatest “enduring contributions to behavioral health care” for that year. He has lectured around the world and is viewed as a thought leader in data driven health quality improvement.