CHADDS FORD, Pa., Nov. 30, 2012 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that its subsidiary, Endo Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) seeking a formal determination whether the original formulation of OPANA ® ER (oxymorphone HCl) was voluntarily removed from the market in 2012 for reasons of safety involving the misuse of the drug; and FDA's immediate suspension of any abbreviated new drug applications (ANDAs) for generic versions of non-tamper resistant formulations of extended-release oxymorphone HCl until FDA has made a determination as to whether the original formulation of OPANA ER was withdrawn from sale for safety reasons. There is currently a non-tamper resistant generic of extended-release oxymorphone available in 7.5mg and 15mg dosage strengths, and if the FDA does not promptly suspend the approval of all non-tamper resistant formulations, all doses of the product will be available in non-tamper resistant versions in January 2013.
Endo reformulated OPANA ER to a version designed to be crush-resistant and launched this reformulated version in March 2012. Current data monitoring abuse rates show a substantial decrease in abuse since the launch of the reformulated product, while simultaneously showing a more than 122 percent increase in abuse rates of the 7.5mg and 15mg non-tamper resistant extended release oxymorphone HCl.
The lawsuit, filed in the U.S. District Court for the District of Columbia, is based on the failure of the FDA to meet its legal obligation to determine in a timely manner whether the old formulation of OPANA ER was withdrawn from the market for reasons of safety. Since its launch, Endo has collected surveillance data on the rates of abuse of oxymorphone HCl from two national programs – the first includes surveillance of substance abusers and the second collects data from U.S. Poison Control Centers. The data show a 59 percent drop in abuse rates of the reformulated OPANA ER which is designed to be crush-resistant. The same data demonstrate a 122 percent increase in abuse rates of non-tamper resistant extended-release oxymorphone HCl.
"Sufficient evidence exists to support the determination that the old formulation of OPANA ER was discontinued for reasons of safety," said Dave Holveck, president and chief executive officer of Endo Health Solutions. "Unless FDA acts before January 1, 2013, the launch of a generic non-crush-resistant OPANA ER will irreparably undermine recent progress in the reduction of abuse and misuse of oxymorphone."Citizens Petition Prior to filing the lawsuit, Endo submitted to FDA two Citizen Petitions in August 2012 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 formulation of the product was discontinued for reasons of safety. 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; and
- 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
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
24/7 market commentary from Jim Cramer and 20+ veteran Wall Street gurus. Get access to the latest trading ideas on stocks, options, and ETFs as well as a real-time forum to see the pros exchanging their investment ideas.
- Jim Cramer + 20 Wall Street pros
- Intraday commentary & news
- Real-time trading forum
- Actionable trade ideas
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV