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Endo Health Offers Prelim. Data Showing 59% Drop in Abuse of Reformulated OPANA ER

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Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that its subsidiary, Endo Pharmaceuticals Inc., has supplemented its OPANA^® ER Citizen Petition to include emerging safety data that demonstrate that the introduction in the first quarter of 2012 of the reformulated OPANA ER (oxymorphone HCl) designed to be crush-resistant, is reducing rates of abuse.

Comparisons of abuse rates for OPANA ER, from the third quarter of 2011 through the third quarter of 2012, demonstrate that the reported rate of abuse of the reformulated OPANA ER was reduced by 59 percent, based on the total number of prescriptions dispensed, versus the rate observed for the non-tamper-resistant formulation of OPANA ER, which is no longer being manufactured by the company.

The initial safety information is based on data collected by two national programs. The first includes surveillance of substance abusers (through the third quarter of 2012) and the second collects data from U.S. Poison Control Centers.

The full data through the third quarter of 2012 strongly suggest that the reformulation of OPANA ER designed to be crush-resistant is having the desired effect on the rates and routes of abuse of the product and this new information supports Endo's position that the original non-crush-resistant formulation was discontinued from the market for reasons of safety.

Posted-In: News FDA

 

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