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CHADDS FORD, Pa.,
Nov. 13, 2012 /PRNewswire/ -- 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.
"Based on this new information, we believe that allowing any non-tamper resistant formulations of long-acting opioids on the market would contribute to a significant increase in abuse," said
Ivan Gergel, M.D., executive vice president, research & development and chief scientific officer of Endo Health Solutions. "Endo is providing this safety information at this time so that FDA has access to the most relevant data as it considers Endo's Citizen Petition. Patient safety, including appropriate use of our products, remains one of Endo's top priorities. We are requesting that the FDA require any generics of OPANA ER to meet the same crush-resistant properties, prior to them being made available to the public."
Endo submitted two Citizen Petitions in
August 2012 to the U.S. Food and Drug Administration (FDA) requesting that any generic formulations of OPANA ER meet the same tamper-resistant properties as the reference drug, as well as determining that the original non-crush-resistant formulation of the product was discontinued for reasons of safety.