July 17, 2017
As part of the FDA’s efforts to address opioid addiction, the agency put an opioid action plan into effect in 2011 to “reduce opioid abuse, dependence, and overdose in the United States.” Part of this plan included a call to pharmaceutical manufacturers to develop and expand access to abuse-deterrent formulations (ADFs) in order to discourage abuse among patients and promote innovation in the industry.
Grünenthal, an international pharmaceutical company with a fully integrated R&D, did not want to see the abuse of opioids prevent legitimate patients from receiving their necessary medication. The Germany-based company set out to create an ADF with a technology that creates a physico-chemical barrier to abuse and, as a result, safeguards patients from the battle of addiction.
Download this case study to learn how Grünenthal overcame various manufacturing challenges and utilized the expertise of a CDMO to develop its abuse-deterrent formulation, INTAC®.