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 Endo submits Citizen Petitions calling for future generics of OPANA ER to be held to the same crush-resistant development standards
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
"As a leader in pain management, Endo supports the appropriate use of long-acting opioids. In 2007, we began the development of a formulation of OPANA ER designed to be crush-resistant because it was the right thing to do for patients, physicians and society in general," said Ivan Gergel, M.D., Executive Vice President, Research & Development, Chief Scientific Officer of Endo Health Solutions. "We are now pleased to offer the reformulated OPANA ER to patients as the only long-acting form of oxymorphone in a variety of strengths that are designed to be crush-resistant. We are encouraging the agency to ensure any future generics of OPANA ER are held to the same development standards before they are made available to the public."
Endo Health Solutions Inc. (Endo) is a US-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates value for patients, providers and payers alike. Learn more at www.endo.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
SOURCE Endo Pharmaceuticals