Endo Health Solutions' ($ENDO) attempt to outmaneuver generic competition by kicking dirt all over its own product has come up short. A federal judge in Washington declined to force the FDA to declare the original formulation of Endo's pain drug Opana ER unsafe.
Opana ER, as well as Purdue Pharma's notorious OxyContin, both go off patent next year, and generic drugmakers like Impax Laboratories ($IPXL) are lining up to get a piece of their lucrative markets. But both companies have since made tamper-resistant forms of the addictive pain drugs that are harder for abusers to crush and use. Endo sued the FDA to try to make it declare that Endo pulled the original Opana ER off the market for safety reasons and so require generic makers to develop tamper-resistant forms. If successful, the move could have eased the pain of generic competition.
While the FDA is off the hook, separately it is considering whether it should require essentially what Endo was asking for or take other measures to limit the use of addictive pain drugs. It has called on pain experts to come to a meeting in February armed with scientific data on pain treatment to help the agency determine if it should set new limits on how long certain drugs can be prescribed and whether those durations should vary for different sources of pain.
At least some FDA experts think the FDA needs to get a handle on the issue, because a panel recently denied a recommendation for a stronger form of hydrocodone from Zogenix ($ZGNX), saying a decision should await an FDA determination on how to discourage abuse of opioids. The panel said the drug, which contains 10 times the dose of hydrocodone in Vicodin, might benefit some patients, but, "why not raise our standard as we move forward for society?" panel member Alan Kaye, chairman of the anesthesia department at the Louisiana State University School of Medicine in New Orleans, said at the meeting.
- read the Bloomberg story
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