Friday, May 10, 2013 5:53 pm
FDA denies request to block generic painkiller
The Associated Press
Endo's Opana ER is a long-acting narcotic drug used to treat moderate and severe pain. Such medications are frequently crushed and then injected or snorted by drug abusers to achieve a euphoric effect.
Last year Endo reformulated Opana with the aim of making the pills more difficult to crush. The company also hoped the move would protect its expiring patent on Opana by blocking approval of generic versions based on the original formulation.
The company petitioned the Food and Drug Administration last year to deny approval to any generic versions, arguing that these products are easier to abuse than its current product.
But the FDA said in an announcement late Friday that it denied the petition, pointing out that Endo's reformulated drug can still be abused.
"We are extremely disappointed and disagree with today's decision," said Rajiv De Silva, CEO of the Malvern, Pa.-based company. Opana ER had sales of nearly $300 million last year and accounted for 10 percent of annual sales for Endo Health Solutions Inc. The company said the decision would reduce its 2013 projected sales by $120 million and reduce earnings by 55 cents per share. The company previously said it expected revenue between $2.8 billion and $2.95 billion and adjusted earnings between $4.40 and $4.70 per share.
The FDA's announcement came after the close of trading on Wall Street. Trading in Endo's stock was halted pending the news announcement during regular trading. Shares fell 35 cents to $34.62 in after-hours trading.
While acknowledging that the new Opana ER is more difficult to crush than the original formulation, "study data show that the reformulated version's extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing," the FDA said in a statement on its website. The agency added that the drug can be prepared for snorting "using commonly available tools and methods."
The FDA decision comes as a surprise since the agency granted a similar request last month by Purdue Pharma, maker of the blockbuster painkiller OxyContin.
The FDA said it will not approve any generic versions of OxyContin based on the original formulation because of its potential for abuse. A patent supporting the original form of the drug expired April 17. The FDA approved labeling for the reformulated version of OxyContin noting that it is harder to abuse.
Purdue Pharmaceuticals LP stopped selling the original version of OxyContin in 2010, about 15 years after the drug was launched, because of widespread concern about people who were crushing the drug and injecting or snorting it to get high off its main ingredient, oxycodone.