Development and Preliminary Experience with an Ease of Extractability Rating System for Prescription Opioids

N. P. Katz Inflexxion, Inc., Newton, MA, USA; Tufts University School of Medicine, Boston, MA, USA

D. C. Buse Harvard Medical School, Boston, MA, USA

S. H. Budman Inflexxion, Inc., Newton, MA, USA; Harvard Medical School, Boston, MA, USA

S. Wing Venuti Inflexxion, Inc., Newton, MA, USA

K. C. Fernandez Inflexxion, Inc., Newton, MA, USA

C. Benoit Inflexxion, Inc., Newton, MA, USA

R. Bianchi Prescription Drug Research Center, Fairfax, VA, USA

D. Cooper Signature Consulting, Rockville, MD, USA

D. R. Jasinski Johns Hopkins Bayview Medical Center, Baltimore, MD, USA

D. E. Smith Haight Ashbury Free Clinics, San Francisco, CA, USA

S. F. Butler Inflexxion, Inc., Newton, MA, USA

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Abstract

One important factor in the abuse potential of an opioid product is the ease with which active drug can be extracted. There are currently no standards for testing or reporting extractability. This article describes the development of an Extractability Rating System for use by the pharmaceutical industry and regulators. Despite several limitations, this effort serves as a call for standardized testing and reporting so that products can be accurately rated, and should help establish goals for drug developers who wish to develop “abuse-resistant” opioid products.

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Development and Preliminary Experience with an Ease of Extractability Rating System for Prescription Opioids

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Development and Preliminary Experience with an Ease of Extractability Rating System for Prescription Opioids

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