Purdue's development of abuse-deterrent formulation opioids as a response to market competition: An industry documents analysis.

Background: The opioid overdose crisis constituted one of the greatest public emergencies in US history. The overpromotion and overprescription of oxycodone and Purdue Pharma's branded formulation, OxyContin, have been implicated as key drivers of the opioid overdose crisis. This study sought to understand Purdue's motivations in developing opioid abuse-deterrent formulations, drugs designed to reduce misuse, abuse, and diversion of prescription opioids. Methods: We conducted a qualitative archival analysis of internal corporate documents archived at the UCSF-JHU Opioid Industry Documents Archive (OIDA). We gathered, coded, and analyzed over 80 internal documents spanning from 1996 to 2010 to reconstruct the timeline of events and motivations that drove Purdue's development and eventual release of an abuse deterrent formulation OxyContin in the US. These primary data included emails, slideshows, and other textual and visual documents. We used regulatory documents and court records as a supplementary data source to triangulate and validate our OIDA-based findings. Results: Purdue initially proposed the development of an abuse-deterrent formulation of OxyContin as a strategy to protect its patents and prevent the introduction of a competing generic formulation of oxycodone. When the company successfully litigated against the introduction of a generic medication, it stopped attempting to develop a reformulation until the regulatory environment changed in a way that would prevent competition if Purdue released the reformulated OxyContin. Conclusions: Pharmaceutical companies may focus on strategies such as abuse-deterrent formulations to protect market share rather than to protect public health. Regulators should be aware of the potential risks of encouraging this approach.