Endo to declare Opana ER addiction risks to settle opioid probe by NY

New York Attorney General Eric Schneiderman

States across the country have been chasing painkiller makers, alleging all kinds of bad behavior in the sales and marketing of opioids. Now one of those cases has stuck, with Endo agreeing to not soft-pedal the risks of taking Opana ER or oversell its crush resistance as conditions of settling an investigation in New York.

Endo Health Solutions ($ENDP) also agreed to pay $200,000 and take a variety of steps to make sure doctors understand the addiction risks to their patients. The company will also stop marketing to and report any physicians they think might be improperly prescribing the opioid, New York Attorney General Eric T. Schneiderman announced Thursday.

Endo, which is based in Dublin but operates out of Malvern, PA, didn't immediately respond to a request for comment from Reuters. Endo makes a number of painkillers, but the AG's investigation focused on Opana ER, which he said had become the drug of choice among many abusers. He said the investigation found that Endo "improperly marketed Opana ER as designed to be crush resistant," providing a "false sense of security to health care providers and their patients," even though Endo's own studies showed the drug could be crushed and ground up.

The announcement said that the probe also found that Endo had its sales representatives "diminish and distort risks associated with Opana ER, including serious dangers involving addiction."

Lawsuits have been filed in Chicago and California against key opioid producers, and a number of other states are investigating, including New Hampshire and Kentucky, as authorities have tried to make drugmakers take some responsibility for what has been termed an epidemic of opioid abuse in the country. Schneiderman's office pointed out that between 2008 and 2011, the number of opioid painkiller prescriptions filled by New York City residents increased by 31%, from approximately 1.6 million to approximately 2.2 million. That rise, he said, could be associated with the 5-fold increase in overdose deaths from opioids in the state, which reached 883 in 2012, from 179 in 2003.

Similar claims have been made in a lawsuit in Chicago against Endo, Purdue Pharma, Teva Pharmaceutical Industries ($TEVA), Johnson & Johnson's ($JNJ) Janssen unit, Depomed ($DEPO) and Allergan ($AGN).

The FDA has also come in for intense criticism from lawmakers and law enforcement officials throughout the country, who think the agency has been lax in approvals of painkillers. After a senator threatened to hold up the confirmation of Dr. Robert Califf over the matter, the newly confirmed FDA director promised that the agency would conduct a sweeping review of its policies. He set out an 8-point plan that he said would "focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief." That includes a re-examination of "the risk-benefit paradigm for opioids" to ensure that the agency considers their wider public health effects.

- here's the release
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