FDA Approves Tamper-Resistant Oxymorphone Formulation

Susan Jeffrey

December 12, 2011

December 12, 2011 — Endo Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved a new crush-resistant formulation of Opana ER.

The product will continue to go by the same brand name and include the same doses of oxymorphone, color, packaging, and tablet size and shape, a statement from the company notes, but it now includes a proprietary technology called INTAC, which is owned by another company, Grünenthal Group in Aachen, Germany.

That technology uses specific polymer compositions and a particular manufacturing process to produce tablet formulations with "crush-resistant properties while preserving desired release characteristics," a statement from Grünenthal, also released today, notes.

"Endo is committed to executing a seamless transition in 2012 from the original formulation to the new formulation," the Endo statement notes. The FDA also signifies there is no significant difference in the rate and extent of absorption of the original oxymorphone formulation, the company states.

The company also announced that the US Patent and Trademark Office will issue a patent on December 13, 2011, to cover the new formulation of Opana ER. This patent is expected to provide patent protection until November 2023. The new patent will be listed in the FDA's Orange Book, the statement notes.

Because the product contains oxymorphone, a CII controlled substance, Opana ER remains a schedule 2 opioid with "all the attendant risks, specifically that the drug has a high potential for abuse."

The statement adds that, "it has not been established that this new formulation of Opana ER is less subject to misuse, abuse, diversion, overdose, or addiction."

"We firmly believe this new formulation of Opana ER, coupled with our long-term commitment to awareness and education around appropriate use of opioids, will benefit patients, physicians, and payers," said Ivan Gergel, MD, executive vice president, research and development, and chief scientific officer at Endo Pharmaceuticals.

This product is one of several new tamper-resistant opioid formulations that have been approved by the FDA.


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