FDA nixes Endo petition to protect Opana ER from generics

Endo Health Solutions lost its bid to thwart generic makers copying its high-powered painkiller Opana ER. The FDA decided Endo's tamper-resistant formula doesn't prevent drug abuse significantly better than earlier versions that weren't designed to deter abuse. That's a blow for Endo, which took in almost $300 million from the drug last year, or 10% of its total sales.

Indeed, Endo ($ENDP) had been hoping to shoo away generic versions of the original Opana formulation, which it no longer sells. The generics have taken their toll on the Opana ER brand. Together with plant problems at its contract manufacturer Novartis ($NVS), the generics took an $84 million bite out of the drug's 2012 sales. Opana ER generated $384 million in 2011. If Endo had prevailed at the FDA, it would have had a shot at reclaiming that chunk of the market and more.

Endo's citizen petition to the FDA cited company data showing that the abuse rate of Opana ER was 79% lower than the abuse rate of generic, non-tamper-resistant versions. The company asked the agency to determine that Endo had pulled its previous formula of Opana ER for safety reasons and to not only refuse to approve new generic versions of the old formula, but to suspend the copies already on the market.

"The FDA decided that the original formulation of Opana ER was not withdrawn from the market for reasons of safety or effectiveness," Endo said in a statement after the ruling. "As a result, generic versions of the original formulation can continue to be approved and marketed."

The FDA also refused Endo's bid for new labeling language that would describe Opana ER's "abuse-deterrent properties," the company said. For its part, the agency said the new Opana formula could be cut or cracked up, ground or even chewed. "We think the public health would not be served if a company can market itself as 'abuse deterrent,' if the scientific evidence did not support that claim," said Douglas Throckmorton, a deputy director in the FDA's Center for Drug Evaluation and Research (as quoted by the Wall Street Journal).

"We are extremely disappointed and disagree with today's decision, and believe that the approval of non-abuse deterrent formulations of long-acting opioids will contribute to a significant increase in prescription drug abuse," CEO Rajiv De Silva said in a statement.

The company had reason to hope for a different decision. Last month, the FDA backed Purdue Pharma's bid to stop non-tamper-resistant versions of its high-powered pain drug OxyContin. Purdue's abuse-deterrent version made its debut in 2010, and, like Endo, the company stopped selling previous versions. The company's patent on OxyContin expired just as the FDA decided not to allow generic versions of the original formula. Plus, some congressional representatives were lobbying the FDA against the generics.

As Endo awaited FDA's decision on its Opana petition, key shareholder Fidelity Investments reportedly began agitating for the company to sell. The investment fund lobbied the board and contacted potential buyers, including Warner Chilcott, coincidentally enough, considering today's news of that company's merger talks with Actavis ($ACT).

- read the Endo release
- see the WSJ story