FDA Shelves Endo Pharma Amid Opioid Abuse

Health and Healthcare

Published: June 9, 2017 10:10 am

Last Updated: January 12, 2020 11:12 am

Opioid addiction is a serious problem in the United States and globally, one that spans all demographics. According to a recent study, drug overdose is the leading cause of accidental death in the United States, with 52,404 lethal drug overdoses in 2015. Opioid addiction is driving this epidemic, with 20,101 overdose deaths related to prescription pain relievers.

In an unprecedented move, the U.S. Food and Drug Administration (FDA) has requested that Endo International PLC (NASDAQ: ENDP) remove its opioid pain medication, Opana ER (oxymorphone hydrochloride), from the market. The agency now believes that the benefits of the drug may no longer outweigh its risks.

This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of the serious blood disorder thrombotic microangiopathy.

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.

Scott Gottlieb M.D., FDA Commissioner, commented:

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. 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.

Shares of Endo were trading down about 15% at $11.72, with a consensus analyst price target of $15.88 and a 52-week range of $9.70 to $24.93.

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