And here comes the FDA!!!!! In a first-of-its kind, the FDA has removed a previously approved opioid medication – Opana ER (oxymorphone hydrochloride) – from the market because “the benefits of the drug may no longer outweigh its risks.”
“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.”
First it was CDC’s pressure on doctors and stigmatizing patients that led to tight restrictions and decreased availability of opioids for those who take them legally and with necessity to manage pain. And now, it’s the regulatory arm of government swinging to the fences.
The agency said that data showed a “significant shift in the route of abuse from nasal to injection following the product’s reformulation.” The agency added that “injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).”
So, the FDA has pulled a pain medication from the hands of those who had been legally prescribed the medication because it is associated with outbreaks of HIV and hepatitis C due to addicts sharing needles. Perhaps a better course of action would be to focus on the problem of sharing needles. Certainly, pulling Opana ER from the market will result in addicts turning to other sources of a high, while the individuals who used the medication legally and responsibly have to suffer or try to find alternative ways to manage their pain.
The FDA’s decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.
According to an FDA press release, “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 Pharmaceuticals 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. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER (emphasis added). Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market.”
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”
More from the FDA press release:
The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval. In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product.
The FDA will continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.”
Chronic pain sufferers and healthcare providers should take notice of this last statement.
Shares of Endo Pharmaceuticals (NASDAQ: ENDP) have plummeted 16% as of this writing.
In a press release, the company had this to say:
Endo International plc (NASDAQ: ENDP) is aware of today’s announcement by the U.S. Food and Drug Administration (FDA) requesting that Endo voluntarily withdraw OPANA® ER (oxymorphone hydrochloride extended release) from the market. Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.
While the benefits of opioids in treating and managing pain are widely recognized, the misuse and abuse of these products have increased greatly in the U.S. As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products.
Despite the FDA’s request to withdraw OPANA® ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients.
FDA Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Meeting Outcome
On March 13 and 14, 2017, the U.S. Food and Drug Administration’s (FDA) Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees were convened to discuss pre- and post-marketing data about the abuse of OPANA® ER, the product’s overall risk-benefit profile, as well as the abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products.
While the Advisory Committee members voted 18 to eight, with one abstention, that the benefits of reformulated OPANA® ER no longer outweigh its risks, more than half expressed their preference that OPANA® ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse.