Endo Health Solutions Inc. (ENDP) lost an effort to stop U.S. sales of generic versions of its extended-release painkiller 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. Impax Laboratories Inc. (IPXL), the maker of a generic version, rose in New York trading.
Endo 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 do so and instead criticized properties of the new Opana ER that were supposed to make the drug resistant to injection and snorting.
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.
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. Impax, 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. (TEVA) and Actavis Inc. (ACT), have applied to sell a generic of the oxymorphone painkiller.
Impax rose 7.7 percent to $17.40 at the close in New York. The shares have declined 22 percent in the past 12 months. Endo had fallen 5.3 percent to $34.97 before being stopped before today’s decision was announced.
The FDA last month granted a similar request from Purdue Pharma LP in relation to the company’s OxyContin pain pill. Chadds Ford, Pennsylvania-based 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.
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