Endo Pharmceutical Sues FDA, Claiming Safety Concerns: Protecting its Pain Killer Opana ER

Earlier this year, the US Senate Finance Committee opened an investigation into several drugmakers, including Endo Pharmaceuticals (ENDP), that sell prescription painkillers and their ties to several patient advocacy groups and various physicians due to “an epidemic” of accidental deaths and addiction resulting from ballooning sales.

At issue have been promotional efforts that fueled increased use and a rise in overdose deaths (back story). Since then, Endo executives have gotten religion, of sorts. The drugmaker is squabbling with the FDA over looming generic versions of its Opana ER pill, which was voluntarily removed from the market just before the Senate probe began.

Late last week, Endo filed a lawsuit against the FDA, claiming the agency failed to officially note the pill was withdrawn for safety reasons and seeks a preliminary injunction to prevent generic versions from being approved for marketing as of next month. This follows two Citizen’s Petitions asking the FDA not to use its original Opana ER as the basis for approving generics.

The legal maneuvering comes now that Endo sells a tamper-resistant version of Opana ER and the drugmaker wants the FDA to approve abbreviated new drug applications that contain data and information demonstrating any proposed ANDA is “similarly crush-resistant as the reformulated OPANA ER designed to be crush-resistant.”

Opana ER accounted for about 14% of Endo’s sales during the first nine onths of 2012, or $236.7 million, according to an SEC filing. Like many pharmaceutical companies, Endo has had a hard time generating sales growth of late.

ENDP Revenue Quarterly data by YCharts

This is only the latest battle over the emergence of generic versions of older opioid painkillers. Last month, for instance, the Canadian Health Minister has rejected pleas to delay approval of a generic form of an older form of OxyContin, prompting criticism that the move will unleash a fresh round of abuse and addiction (see back story to Pharma news).

Endo is making a similar argument about safety concerns. In a press release announcing the lawsuit against the FDA, a sub headline declares that “surveillance data show (a) dramatic decrease in abuse rates of reformulated OPANA ER designed to be crush-resistant when compared to (the older) non-tamper resistant formulation.”

“Sufficient evidence exists to support the determination that the old formulation of OPANA ER was discontinued for reasons of safety,” Endo ceo Dave Holveck says in thestatement. “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.”

Of course, Endo stands to gain if the FDA delays or denies approvals for generic versions of the older formulation of Opana ER. What the FDA will – and should – be determined based on law. But such concern over safety issues might have been won the company more points a few years ago, when critics say several drugmakers, including Endo, helped squelch a REMS, or risk evaluation and mitigation strategy, that the FDA had proposed.

This tactic and other moves – such as promotional messaging designed to convince physicians that the pills are not addictive, but some people are more susceptible to addiction – made it possible for sales of the older pills to continue rising until tamper-resistant versions became available. Emphasizing safety is to be commended, but for Endo execs to wrap themselves in a cloak of safety at this stage comes off as a wee bit too convenient.

To read the remainder of this article, go to Pharmalot.

Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily.

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