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Regulatory Implications for the Pharmaceutical Industry in the Midst of the Opioid Abuse Crisis

by Uma Sharma

Posted on 8/10/2017 1:38 PM

In the midst of an ongoing opioid epidemic in the United States, the Food and Drug Administration (FDA) asked Endo Pharmaceuticals to withdraw OPANA ER from the market in June 2017. 

This is the first time a sponsor has been asked to withdraw a marketed product for abuse reasons.  Typically a marketed drug is withdrawn from the market when there are concerns over the risk/benefit profile when the drug is being used as prescribed.  In this case, the reason for withdrawal was made based how the drug was being abused (used “off-label”). 

FDA based their decision on a review of all post-marketing data.  The data demonstrated a “significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation,” it said. “Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C,” it added. Both viruses spread when people share needles.

OPANA ER was approved by the FDA in 2006, and Endo did submit a re-formulated version in 2012 (also called OPANA ER) with claims that this would make the drug resistant to abuse by snorting or injecting. This reformulation safety claim was rejected by an 18-8 vote in an FDA Advisory Committee meeting with members ruling it was “not expected to meaningfully reduce abuse.” 

Endo agreed in early July to comply with Agency’s request to remove OPANA ER from the market. According to FDA Commissioner Scott Gottlieb, M.D. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

Peggy Zorn, MMS Associate Director Regulatory Affairs, Submissions & Transparency weighed in on the regulatory dilemma of Endo and other companies that market opioids.  “The FDA convened a public meeting in July of 2017 to bring together experts to discuss the effectiveness of opioid drugs with abuse-deterrent properties, using real world data.  Pharmaceutical companies who market opioids need to be aware of the increased public pressure and FDA focus on addressing the crisis of opioid addiction.  Risk Evaluation and Mitigation Strategies (REMS) developed with the Agency for all opioids, including those with abuse-deterrent properties, will be under increased scrutiny.  Companies working in this area will need to plan to conduct additional studies.  For example, opioids with abuse-deterrent properties will need to measure whether these products actually do produce a significant decrease in opioid abuse.”

During the FDA meeting on July 11th, FDA announced that immediate-release formulations of opioids will now be subject to the same REMS program as extended-release opioids.  FDA also announced that drug manufactures of immediate-release opioids will now be required to provide training to clinicians, a requirement already in place for extended-release formulations.

While there is a need to understand the value of opioid painkillers and their role in analgesia; public safety concerns are equally compelling given the current CDC data on number of opioid-related deaths in the country.  It is clear that the FDA and other agencies are looking very closely at this data.

Regulatory Submission Support Based on Strong Science and Strength of Process. The difference is in the data!