CHADDS FORD, Pa., Nov. 30, 2012 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that its subsidiary, Endo Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) seeking a formal determination whether the original formulation of OPANA ® ER (oxymorphone HCl) was voluntarily removed from the market in 2012 for reasons of safety involving the misuse of the drug; and FDA's immediate suspension of any abbreviated new drug applications (ANDAs) for generic versions of non-tamper resistant formulations of extended-release oxymorphone HCl until FDA has made a determination as to whether the original formulation of OPANA ER was withdrawn from sale for safety reasons. There is currently a non-tamper resistant generic of extended-release oxymorphone available in 7.5mg and 15mg dosage strengths, and if the FDA does not promptly suspend the approval of all non-tamper resistant formulations, all doses of the product will be available in non-tamper resistant versions in January 2013.
Endo reformulated OPANA ER to a version designed to be crush-resistant and launched this reformulated version in March 2012. Current data monitoring abuse rates show a substantial decrease in abuse since the launch of the reformulated product, while simultaneously showing a more than 122 percent increase in abuse rates of the 7.5mg and 15mg non-tamper resistant extended release oxymorphone HCl.
The lawsuit, filed in the U.S. District Court for the District of Columbia, is based on the failure of the FDA to meet its legal obligation to determine in a timely manner whether the old formulation of OPANA ER was withdrawn from the market for reasons of safety. Since its launch, Endo has collected surveillance data on the rates of abuse of oxymorphone HCl from two national programs – the first includes surveillance of substance abusers and the second collects data from U.S. Poison Control Centers. The data show a 59 percent drop in abuse rates of the reformulated OPANA ER which is designed to be crush-resistant. The same data demonstrate a 122 percent increase in abuse rates of non-tamper resistant extended-release oxymorphone HCl.
"Sufficient evidence exists to support the determination that the old formulation of OPANA ER was discontinued for reasons of safety," said Dave Holveck, president and chief executive officer of Endo Health Solutions. "Unless FDA acts before January 1, 2013, the launch of a generic non-crush-resistant OPANA ER will irreparably undermine recent progress in the reduction of abuse and misuse of oxymorphone."Citizens Petition Prior to filing the lawsuit, Endo submitted to FDA two Citizen Petitions in August 2012 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 formulation of the product was discontinued for reasons of safety. Specifically, Endo's CPs call for:
- a determination that the non-crush-resistant OPANA ER was discontinued from sale for reasons of safety when not taken as prescribed
- the requirement that any abbreviated new drug applications (ANDA) referencing OPANA ER contain data and information demonstrating that the proposed ANDA product is similarly crush-resistant as the reformulated OPANA ER designed to be crush-resistant
- the classification of crush-resistant technologies, such as the reformulated, crush-resistant OPANA ER, as a new dosage form in the FDA's Orange Book; and
- confirmation that any ANDA referencing the original non-crush-resistant OPANA ER will not be identified in the FDA's Orange Book as therapeutically equivalent to the reformulated OPANA ER designed to be crush-resistant
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