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Endo faces industry-first FDA call to pull its opioid painkiller

Misuse of Opana ER has been associated with a ‘serious’ HIV and hep C outbreaks


In an industry first, the Food and Drug Administration (FDA) has called on Endo Pharmaceuticals to pull its extended-release opioid painkiller Opana ER from the market - 11 years after its first approval - due to its potential for drug misuse.

The painkiller was first approved in 2006 to manage moderate-to-sever pain when a continuous, around-the-clock opioid analgesic was needed for an extended period of time, but an FDA advisory panel has now concluded “the risk no longer outweighs its benefits”.

Endo did take steps to make the painkiller more resistant to physical and chemical tampering, with a new formulation approved in 2012, but data showed a shift in the method of abuse from nasal to injection.

FDA commissioner Scott Gottlieb said: “We are facing an opioid epidemic - a public health crisis, and we must take all the necessary steps to reduce the scope of opioid misuse and abuse.”

Opioid overdoses killed 33,000 Americans in 2015 - with half of those involving a prescription opioid. In the case of Opana ER its misuse has been associated with ‘serious’ outbreaks of HIV, Hepatitis C and a blood disorder known as thrombotic mircoangiopathy.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

“When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market. This action will protect the public from further potential abuse of this product,” she added.

Endo’s shares dropped to 13.6% following the request and the Irish drug maker said that it’s “evaluating the full range of potential options”. However if the firm doesn’t comply the regulatory agency can take legal action to force it to do so.

Last year, Opana generated sales of $159m for Endo, down from its peak of around $300m and the drug has annual sales of around $4bn.

Previously Purdue Pharma’s opioid painkiller Oxycontin was removed from the market when an abuse-resistant form became available, but the privately-held pharmaceutical company removed the drug from the market without a request from the FDA.

Article by
Gemma Jones

12th June 2017

From: Regulatory



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