NEW YORK (AP) – Endo Pharmaceuticals Holdings Inc. has announced that regulators want more information about a new version of its pain drug Opana ER before they will allow Endo to start selling it.
The company said the Food and Drug Administration did not approve a version of Opana ER that is designed to be crush-resistant. The change would make it more difficult to abuse the drug, which is designed to release a painkiller over 12 hours. Extended-release drugs can often be abused if they are crushed, which defeats the time-release chemical.
Shares of the Chadds Ford, Pa., company lost $1.55, or 4.4 percent, to $33.56 in midday trading.
Endo did not say why the FDA did not approve the new version of the drug. However, it said the agency did not require that Endo run new clinical trials, and it hopes to respond to the agency by the middle of this year. The company said the FDA will probably take six months to review that response after it is submitted. The process could have taken longer and cost significantly more money if new studies were required.
While regulators and companies have been pushing to get abuse-resistant painkillers on the market, delays have been common. In a note to clients, Jefferies & Co. analyst Corey Davis said an abuse-resistant form of OxyContin was put through an extended FDA review, and so were two drugs made by King Pharmaceuticals Inc. The FDA did not approve any of those drugs based on their initial applications, asking for more information instead.
Davis said he has always expected the crush-resistant version of Opana ER to reach the market in January 2012. However he said some investors may not have expected the delay or were hoping for an earlier approval.
Filed Under: Drug Discovery
