Endo Health Solutions Inc., the maker of the painkillers Percocet and Lidoderm, lost an effort to stop U.S. sales of generic versions of its extended-release pill Opana that don’t have tamper-resistant qualities.
The Food and Drug Administration’s decision today means copycats of Endo’s older Opana ER without abuse-deterrent technology will remain on the market. The competition may cut sales this year by as much as $120 million and reduce profit by as much as 55 cents a share, Chadds Ford, Pennsylvania-based Endo said in a statement.
Impax Laboratories Inc., based in Hayward, California, became the first to sell a generic of the original Opana ER in January. Other companies, including Teva Pharmaceutical Industries Ltd. and Actavis Inc., have applied to sell a generic of the oxymorphone painkiller.
“The company is actively pursuing cost-reduction actions that will reduce the earnings effect of FDA’s decision,” Endo said in the statement. The company on May 7 had reiterated a forecast for 2013 profit excluding certain items of $4.40 a share to $4.70 a share.
Endo had fallen 5.3 percent to $34.97 before the shares were halted at 3:21 p.m. New York time ahead of today’s announcement. Impax rose 7.7 percent to $17.40 at the close.
Endo had sought a determination from the FDA that the original Opana ER was taken off the market for safety reasons, a determination that would have meant less competition for its newer version. The FDA declined to make that determination, instead criticized properties of the new Opana ER that were supposed to make the drug resistant to injection and snorting.
Opana ER has crush-resistant features though it can be manipulated through cutting or chewing, the FDA said. Inconclusive post-marketing studies show the reformulated version may have a higher percentage of abuse via injection than the original version, the FDA said in a statement.
“We are extremely disappointed and disagree with today’s decision, and believe that the approval of non-abuse deterrent formulations of long-acting opioids will contribute to a significant increase in prescription drug abuse,” Rajiv De Silva, Endo’s chief executive officer, said in the statement.
Opana and extended-release Opana generated $299 million in revenue last year, or 10 percent of Endo’s total sales, down from $384 million in 2011.
The FDA last month granted a similar request from Purdue Pharma LP in relation to the company’s OxyContin pain pill. Endo and Stamford, Connecticut-based Purdue pulled the original versions of their painkillers from the market and reintroduced them with advancements that keep addicts from being able to crush the pills for a greater high. The FDA has established standards for drugmakers to prove their painkillers are abuse-resistant though it hasn’t required tamper protection.
“FDA continues to encourage the development of abuse-deterrent formulations of opioids to help reduce prescription drug abuse and to positively affect public health. FDA reviews every application on its own merits, based on applicable scientific and legal standards,” the agency said in the statement.