US Opioid Epidemic: FDA Requests the Removal of Opioid from the Market

June 14, 2017

On Thursday, June 8th, the FDA requested that Endo Pharmaceuticals remove Opana®  ER (oxymorphone hydrochloride), an opioid pain medication, from the market.

History with FDA

The FDA originally approved Opana ER 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 2011, the FDA approved a reformulated version of Opana ER.  This new version of the drug was “designed with physicochemical properties intended to make the drug resistant to physical and chemical manipulation for abuse by snorting and injecting.”  Although the product did meet all of 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.”

In 2012, Endo Pharmaceuticals replaced the original formulation of Opana ER with the reformulated product.  At the same time, the company petitioned the FDA “to determine that the original Opana ER was withdrawn from market due to safety concerns (which would result in withdrawing generic products referencing original Opana ER from the market).”  In 2013, Endo’s petition was denied and the Agency issued a statement regarding its assessment of Opana ER’s reformulation.

FDA’s Recent Request

In March of this year, “an independent FDA advisory committee met to discuss the abuse patterns and other safety concerns related to Opana ER and voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.”

Last week the FDA asked Endo Pharmaceuticals to voluntarily remove the reformulated product from the market.  If the company chooses not to remove the product, FDA states that it “intends to take steps to formally require its removal by withdrawing approval.”  Additionally, the Agency notes that in the meantime, it is working to ensure that health care professionals as well as other individuals are aware of the serious risks associated with the abuse of the drug.

The FDA’s announcement states that it plans to continue its examination of “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.”

For additional information, view FDA’s press release.

Do you manufacture an FDA-regulated product?  Our regulatory group can help you obtain FDA approval of your product.  After that, our quality & compliance group can help ensure that your product is compliant with all FDA requirements.  To learn more about our services and how we can help you, contact us today.




Agency Alerts

June 14, 2017

Opioid Epidemic: Everything You Need to Know About FDA’s Action Plan to Reduce Opioid Abuse

Additional details on the opioid epidemic are available in our FDA News article, entitled "Califf Pledges to Review FDA’s Opioid Policies to Address US Opioid Epidemic" In early February, Dr. Robert...

Read More
Agency Alerts General Regulatory

June 14, 2017

Califf Pledges to Review FDA’s Opioid Policies to Address US Opioid Epidemic

On February 4, Robert Califf, MD, FDA’s Deputy Commissioner for Medical Products and Tobacco, released a new plan to reassess the Agency’s approach to opioid regulation. The plan includes a number of...

Read More
Agency Alerts General Regulatory

June 14, 2017

Opioid Epidemic: FDA “Ups the Ante” on Labeling Requirements for Opioid Painkillers

On Tuesday, March 22 the FDA announced class-wide safety labeling changes for all immediate-release opioid painkillers. FDA stated that these changes are being made as part of the Agency’s...

Read More