Tag Archives: Endo Pharmaceuticals

Generic Opana to remain on the market: FDA

PillsThe U.S. Food and Drug Administration said Friday it will continue to allow sales of the generic version of the painkiller Opana that does not include an abuse-resistant feature.

Opana’s manufacturer, Endo Pharmaceuticals, had submitted a petition to the agency asking it to ban generic forms of the painkiller, which Endo has reformulated as “Opana ER” to make it harder to abuse. That petition was denied by the FDA, which said Endo’s reformulation was not significantly safer than the original version:

While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing. Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.

Endo’s petition came after Purdue Pharma successfully asked the FDA to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make it more difficult to crush, break, or dissolve.

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Pain advocacy group shuts doors amid Senate probe

A U.S. Senate investigation into financial ties between producers of prescription painkillers and organizations that champion such drugs was announced Tuesday, just after the American Pain Foundation, the nation’s largest organization for pain patients, said it would shut down. The group said in a statement on its website that its closure was due to “irreparable economic circumstances.”

APF – which received 90 percent of its $5 million in funding in 2010 from the drug and medical-device industry – came under fire in December over its ties to pharmaceutical companies.

The Senate investigation was launched amid concerns that doctors and consumers aren’t getting accurate information about the risks of powerful opiate painkillers. According to the New York Times, pharmaceutical companies that received notice of the probe include OxyContin maker Purdue Pharma; Endo Pharmaceuticals, which makes Percocet; and Johnson & Johnson, which markets Duragesic.

APF – which was also sent a letter – claims on its website that “misguided state and federal policies are impeding access to appropriate and reasonable medical care for people struggling with pain, and deterring even the most compassionate medical providers from treating anyone with pain conditions.”

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