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Endo Health Solutions Inc. (Formerly Known as Endo Pharmaceuticals Holdings Inc.) (ENDP) Launches 7.5mg and 15mg Strengths of Reformulated, Designed to be Crush-Resistant, OPANA® ER


12/12/2012 8:55:35 AM

CHADDS FORD, Pa., Dec. 11, 2012 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that its subsidiary, Endo Pharmaceuticals Inc., has launched 7.5mg and 15mg strengths of its reformulated, designed to be crush-resistant, OPANA® ER (oxymorphone HCl) product. Now commercially available, the 7.5mg and 15mg options complete the launch of all approved strengths of the reformulated version of OPANA ER with INTAC® technology. The product is now available in seven dosage strengths: 5, 7.5, 10, 15, 20, 30 and 40mg.

"Considering that a substantial amount of abuse and misuse of opioid products is performed by manipulating the tablet through crushing and powdering, we are excited to offer patients and healthcare professionals a full line of strength options of the reformulated, designed to be crush-resistant, OPANA® ER," stated Julie McHugh, chief operating officer, Endo Health Solutions. "Now healthcare professionals and patients have seven strength options for extended release oxymorphone (HCl) in a version designed to be crush-resistant. We see this line completion as an important step forward for responsible pain management."

With the launch of 7.5mg and 15mg OPANA ER designed to be crush-resistant, Endo filed a false advertising suit against Actavis calling for the company to cease and desist promoting its non-crush-resistant extended release oxymorphone HCl product as A-B rated, or bio-equivalent, to the reformulated OPANA ER. The lawsuit was filed earlier today, Tuesday, December 11, 2012.

As Endo reported in November, surveillance data collected by national independent sources through the third quarter of 2012 suggest that the introduction of reformulated OPANA ER designed to be crush-resistant in February reduced abuse rates of the product when compared to the non-crush-resistant version that Endo discontinued in May. Additionally, rates of abuse for the non-crush-resistant 7.5mg and 15mg oxymorphone HCl tablets marketed by Actavis appear to have increased more than 122 percent since Endo launched its reformulated OPANA ER version.

About OPANA ER

OPANA® ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

WARNING: ABUSE POTENTIAL, LIFETHREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL

Abuse Potential

OPANA ER contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient's risk for opioid abuse or addiction prior to prescribing OPANA ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OPANA ER for signs of misuse, abuse, and addiction during treatment.

Lifethreatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of OPANA ER, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential and OPANA ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OPANA ER or following a dose increase. Instruct patients to swallow OPANA ER tablets whole. Crushing, dissolving, or chewing OPANA ER can cause rapid release and absorption of a potentially fatal dose of oxymorphone.

Accidental Exposure

Accidental ingestion of OPANA ER, especially in children, can result in a fatal overdose of oxymorphone.

Interaction with Alcohol

The coingestion of alcohol with OPANA ER may result in an increase of plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while on OPANA ER.

About Endo

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 Health Solutions Inc.


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