News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Endo Health Solutions Inc. (Formerly Known as Endo Pharmaceuticals Holdings Inc.) (ENDP) Supplements Citizen Petition With Preliminary Data Showing a 59% Drop in Abuse of the Reformulated, Designed to be Crush-Resistant, OPANA® ER


11/14/2012 8:06:11 AM

CHADDS FORD, Pa., Nov. 13, 2012 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that its subsidiary, Endo Pharmaceuticals Inc., has supplemented its OPANA® ER Citizen Petition to include emerging safety data that demonstrate that the introduction in the first quarter of 2012 of the reformulated OPANA ER (oxymorphone HCl) designed to be crush-resistant, is reducing rates of abuse.

Comparisons of abuse rates for OPANA ER, from the third quarter of 2011 through the third quarter of 2012, demonstrate that the reported rate of abuse of the reformulated OPANA ER was reduced by 59 percent, based on the total number of prescriptions dispensed, versus the rate observed for the non-tamper-resistant formulation of OPANA ER, which is no longer being manufactured by the company.

The initial safety information is based on data collected by two national programs. The first includes surveillance of substance abusers (through the third quarter of 2012) and the second collects data from U.S. Poison Control Centers.

The full data through the third quarter of 2012 strongly suggest that the reformulation of OPANA ER designed to be crush-resistant is having the desired effect on the rates and routes of abuse of the product and this new information supports Endo's position that the original non-crush-resistant formulation was discontinued from the market for reasons of safety.

"Based on this new information, we believe that allowing any non-tamper resistant formulations of long-acting opioids on the market would contribute to a significant increase in abuse," said Ivan Gergel, M.D., executive vice president, research & development and chief scientific officer of Endo Health Solutions.  "Endo is providing this safety information at this time so that FDA has access to the most relevant data as it considers Endo's Citizen Petition. Patient safety, including appropriate use of our products, remains one of Endo's top priorities. We are requesting that the FDA require any generics of OPANA ER to meet the same crush-resistant properties, prior to them being made available to the public."

Endo submitted two Citizen Petitions in August 2012 to the U.S. Food and Drug Administration (FDA) 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 non-crush-resistant formulation of the product was discontinued for reasons of safety.

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.


Read at BioSpace.com

comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES