Opioids are drugs that act on the nervous system to relieve pain. Continued use and abuse can lead to physical dependence and withdrawal symptoms. Opana ER is among one of the many opioid drugs in the market today. Recently, FDA requested that the manufacturer voluntarily remove reformulated Opana ER from the market. FDA has made this request in fear that the drug’s risks now outweigh the benefits of the drug. “We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said 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.”
Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. This new formulation showed a spike in abuse by means of injection.
Contribution by Bryce Stevenson, SLF Summer Intern