Endo Health Solutions to end misleading claims, AG says

ALBANY — The manufacturer of a heavily abused painkiller has agreed to stop what state Attorney General Eric Schneiderman called “false and misleading claims” about the safety of its drug and to avoid unscrupulous health care providers who have helped fuel the opioid epidemic on Long Island and nationwide.

Schneiderman said the legal agreement he struck Wednesday on the long-acting opioid Opana ER requires the company, Endo Health Solutions Inc., to pay a $200,000 penalty.

In 2011, Nassau County issued a public health alert warning of increasing abuse of Opana ER — with hundreds of people each month seeking treatment for addiction.

“The public health crisis created by improper opioid prescribing in New York remains pervasive and extremely dangerous,” Schneiderman said. He said a key to avoiding addiction is to continue to advise consumers on the risk of addiction in taking prescription painkillers.

Opana ER contains oxymorphone.

The company confirmed the agreement, saying it is committed to patient safety and health

“We therefore support efforts to curb opioid prescription abuse and we believe that enhancing those efforts, including through anti-diversion programs, is an effective use of time and resources,” said Matthew Maletta, executive vice president and chief legal officer at Ireland-based Endo.

“We also welcome the support and input from the New York attorney general and other stakeholders as we continually evolve and improve our anti-abuse programs while maintaining appropriate access to safe and effective medications,” he said.

As an example of a false or misleading statement, the agreement states that the company in 2012 claimed on its website that “most health care providers … agree that patients treated with prolonged opioid medicines usually do not become addicted.”

In company training, sales people were instructed to say feelings of withdrawal were not symptoms of addiction to the drug, but Schneiderman said withdrawal is a classic symptom of addiction. Sales people were instructed to dismiss these symptoms as “pseudoaddiction,” not true addiction.

Schneiderman also said the company’s claim that the pills were “crush resistant” were untrue. Opioids are often crushed to powder by abusers so it can be snorted or injected. But state investigators found the company’s own studies showed the pill could be ground up, Schneiderman said.

In the settlement, the company agreed to provide accurate information on the risk of addiction on its product, stop marking Opana ER as crush resistant and create a program to make sure the drug isn’t sold to health care providers “it suspects of engaging in abuse and illegal diversion of opioids, and for Endo to cease marketing opioids to problem prescribers.”

The company had told investors last month that it anticipates more than $4 billion in revenues this year. In 2013, the company failed to get the federal Food and Drug Administration to block generic versions of Opana ER, which would have extended patents about to expire. The company warned that allowing generic forms of its drug would lead to more abuse than the brand-name drug.

By Michael Gormley

michael.gormley@newsday.com@GormleyAlbany

Michael Gormley has worked for Newsday since 2013, covering state government, politics and issues. He has covered Albany since 2001.