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Endo withdraws product as FDA secures step in opioid crisis fightback

Published on 10/07/17 at 11:06am

The FDA took the unusual step to ask Endo Pharmaceutical to voluntarily withdraw its opioid painkiller, Opana ER, from the market one month ago. It was the first time that the agency had recommended such a step and nobody was quite sure how the company in question would react.

It seemed to take Endo by surprise and it reacted by stating: “Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.”

This non-definitive answers gave rise to speculation whether it would chose to fight the decision, meaning its situation could become difficult if the FDA decided to fightback, or to acquiesce to the request.

In the end, Endo chose to voluntarily withdraw its product – taking a $20 million hit in the process. The company released that it had secured net sales of $35.7 million in the first quarter of 2017.

Opana ER attracted a lot of attention as an opioid painkiller contributing to the crisis wracking North America, after it had been widely abused only for it to be reformulated but without succeeding in stymying the abuse.

Its initial formulation was found to be too vulnerable to crushing, which could then be snorted. Once reformulated, a new issue emerged where it was injected – leading to serious increases to levels of HIV and hepatitis C in certain communities.

Endo released a statement that did not back down on its claim that its product was suitable for pain relief: “Endo reiterates that neither the FDA's withdrawal request nor Endo's decision to voluntarily remove OPANA ER from the market reflect a finding that the product is not safe or effective when taken as prescribed. To the contrary, Endo remains confident in the clinical research and other data demonstrating OPANA ER's safety and efficacy, as well as its favourable risk-benefit profile when used as intended in appropriate patients.”

On the same day that Endo announced the withdrawal of its product, two new lawsuits were launched at the company from California.

Two counties, Santa Clara and Orange County based their legal actions on the proviso that the pharmaceutical company had falsely implied that the reformulated pills were able to prevent abuse. It seems Endo is not out of the woods yet, even after withdrawing its product.

Ben Hargreaves

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