Endo Announces FDA Approval of a New Formulation of Opana ER Designed to be Crush-Resistant
CHADDS FORD, Pa., Dec. 12, 2011 /PRNewswire/ -- Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of Opana ER designed to be crush-resistant.
"FDA's approval of this new formulation of Opana ER is an important milestone for both the Long Acting Opioid category as well as Endo's branded pharmaceutical portfolio," said Dr. Ivan Gergel, M.D., executive vice president, R&D and chief scientific officer, Endo Pharmaceuticals. "Patient safety is our top concern and addressing appropriate use of opioids is a responsibility that we take very seriously. We firmly believe this new formulation of Opana ER, coupled with our long-term commitment to awareness and education around appropriate use of opioids will benefit patients, physicians and payers."
Endo is committed to executing a seamless transition in 2012 from the original formulation to the new formulation, which utilizes the proprietary INTAC™ technology owned by Grunenthal, a partner in the development of the product. The new formulation will continue to be called Opana ER with the same dosage strengths, color and packaging and similar tablet size and shape. Also, the FDA approval signifies that there is no significant difference in the rate and extent of absorption of the therapeutic ingredient between this new formulation and the original formulation of Opana ER.
Endo also announced that the U.S. Patent and Trademark Office will issue patent number 8,075,872 on Dec. 13, 2011. The patent covers the new formulation of Opana® ER and is expected to provide protection until November 2023. This new patent will be listed in the FDA's Orange Book with respect to the new formulation of Opana ER.
Because Opana ER contains oxymorphone, a CII controlled substance, it remains a Schedule II opioid with all the attendant risks, specifically that the drug has a high potential for abuse. Use, misuse, or abuse of the drug may lead to physical dependence or addiction (addiction is sometimes referred to as "psychological dependence"). In addition, alteration of the tablet in any manner poses significant risks of overdose and death. It has not been established that this new formulation of Opana ER is less subject to misuse, abuse, diversion, overdose, or addiction. The Full Prescribing Information contains warnings about the potential for abuse, diversion, overdose and addiction, including a boxed warning (see below).
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE.
See full Prescribing Information for complete boxed warning.
Opana ER contains oxymorphone which is an opioid agonist
and a Schedule II controlled substance with an abuse liability
similar to other opioid analgesics.
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Opana ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Opana ER is NOT intended for use as an as needed analgesic.
Opana ER tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed as this leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, prescription or non-prescription medications containing alcohol. Co-ingestion of alcohol with Opana® ER may result in a potentially fatal overdose of oxymorphone.
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company with a diversified business model, operating in three key business segments – branded pharmaceuticals, generics and devices and services. We deliver an innovative suite of complementary products and services to meet the needs of patients in areas such as pain management, pelvic health, urology, endocrinology and oncology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries American Medical Systems, HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit http://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
CONTACT: Investors/Media: Blaine Davis, +1-610-459-7158; Media: Kevin Wiggins, +1-610-459-7281; Investors: Jonathan Neely, +1-610-459-6645
Web Site: http://www.endo.com
Posted: December 2011
- Opana ER Endo Pharmaceuticals Inc. - Treatment for Moderate-to-Severe Pain - June 22, 2006
- Endo Files Responses to FDA's Approvable Letters on NDAs for Oxymorphone ER and IR Tablets - December 22, 2005