Endo Pharmaceuticals Announces Reformulated Version Of OPANA® ER With INTAC® Technology Designed To Be Crush-Resistant Accounts For More Than 90 Percent Of OPANA ER Total Prescription Volume
CHADDS FORD, Pa., Sept. 6, 2012 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP), today announced that, according to the latest IMS data estimates, the reformulated OPANA ® ER (oxymorphone HCl) incorporating Grunenthal's INTAC ® Technology designed to be crush-resistant accounts for more than 90 percent of the OPANA ER total prescription volume.
"Patient safety, including appropriate use of our products, remains one of Endo's top priorities, and we are proud to announce that almost all remaining inventory of the original formulation of OPANA ER has been utilized," stated Julie McHugh, Chief Operating Officer for Endo Health Solutions. "We are passionate about the benefits of our reformulated product and hope to collaborate with the FDA to make crush-resistant formulations of long acting opioids the new standard of entry to the market."
With the intent of helping drive appropriate use of OPANA ER, Endo ceased production of the original formulation and began manufacturing only the version employing INTAC Technology in February 2012. For information about INTAC technology, visit: www.intac.grunenthal.com.
Additionally, Endo recently submitted two Citizen Petitions (CP) encouraging the U.S. Food and Drug Administration (FDA) to partner with the company in an effort to employ standards that will better manage patient access to vital pain management medications like OPANA ER while also helping drive appropriate use of the products.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
- 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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