January 10, 2018

FDA Continues to Shift Opioid Strategy

Midway through 2017, the FDA announced a variety of new opioid policy initiatives, laying the groundwork for significant policy change through 2018.

The second half of last year saw Endo Pharmaceuticals removing the abuse-deterrent Opana ER from the market following FDA request due to public health concerns. This was then followed by a series of public meetings that questioned the effectiveness of abuse-deterrent opioids.

Furthermore, in attempt to better influence opioid prescribing practices, the FDA announced plans to expand the Risk Evaluation and Mitigation Strategy (REMS) program used for extended release (ER) opioids to immediate release (IR) opioids, which make up an estimated 90% of opioid prescriptions.

Regarding new opioid approvals, the FDA did approve three new opioids in the first half of 2017, but denied the approval of Rexista (oxycodone) in September. While further action on these goals remains to be seen, these policy changes indicate that the FDA may take a tougher stance on new opioid approvals in the future, and even emphasize the development and approval of non-opioid alternatives. This seems especially likely as the FDA works with drug companies who are developing non-opioid pain medications.

In 2017, the FDA granted Fast Track designation to tanezumab, a non-opioid biologic in Phase 3 development for the treatment of chronic low-back pain and osteoarthritis. Tanezumab is one of many new drugs in development that target non-opioid pain neuropathways in the brain, in an attempt to reduce pain while avoiding opioid neuropathways that trigger adverse effects.

A Fast Track designation increases collaboration between drug developers and the FDA for drugs that treat unmet medical needs, in this case pain management without opioid side effects. This demonstrates the FDA’s willingness to explore these new medications, and with more research underway, we could see potential drug approvals in the future that offer viable opioid alternatives.

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