Endo Works With FDA on Request to Pull Opioid Pain Pill

  • Drug prescribed 50,000 times a month in the U.S., CEO says
  • ‘Little disappointed’ that FDA didn’t collaborate, CEO says

Endo International Plc is working with the U.S. Food and Drug Administration to address the agency’s unprecedented request that it pull the powerful opioid pain medication Opana ER off the market because of potential abuse, Chief Executive Officer Paul Campanelli said.

The FDA asked Endo to stop selling the drug last week, the first time the agency made such a move amid what it calls a public-health crisis. The agency is trying to contain an outbreak of dangerous infections by addicts who abuse drugs like Opana ER that are approved for legitimate pain relief.

Opana ER is prescribed about 50,000 times a month and Endo has to be mindful of the needs of those patients who are using the pill as intended, Campanelli said Tuesday during a presentation at the Goldman Sachs Healthcare Conference.

“The request to voluntarily remove the product is one thing, but it comes with a lot of other questions that are unanswered,” he said. “We are attempting to communicate with the FDA to find out what they would like us to do.”

After Endo reformulated the drug to try and reduce its potential for abuse, many drug users went from crushing and snorting the pill to injecting it. That led to an outbreak of HIV and hepatitis C, the FDA said Friday, when it made its decision public. The move sent Endo’s shares plunging 17 percent that day. The stock dropped another 3.4 percent Monday and traded up 0.6 percent as of 3:24 p.m. New York time.

Endo expected a more collaborative approach when company officials attended a meeting with the FDA last Thursday, the CEO said. Rather than getting a request to remove the product from the market, Campanelli said he had anticipated Endo would be able to keep selling the painkiller while working on issues like the label, the formulation and other strategies to mitigate its risks.

“While it’s not necessarily a surprise, we were probably a little disappointed in terms of the approach,” he said. “Our goal was to always collaborate with the agency in order to address the situation.”

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