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CHADDS FORD, Pa. — Endo Pharmaceuticals has received approval from the Food and Drug Administration for a new formulation of Opana ER designed to be crush-resistant.
Endo said Monday that it expects a seamless transition next year from the original formulation of the narcotic pain reliever to the new formulation, which employs the proprietary INTAC technology owned by Grunenthal, a partner in the development of the product.
The new product will continue to be called Opana ER with the same dosage strengths, color and packaging, as well as similar tablet size and shape, according to Endo
"FDA’s approval of this new formulation of Opana ER is an important milestone for both the long-acting opioid category as well as Endo’s branded pharmaceutical portfolio," stated Dr. Ivan Gergel, executive vice president, R&D, and chief scientific officer at Endo Pharmaceuticals. "Patient safety is our top concern, and addressing appropriate use of opioids is a responsibility that we take very seriously. 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."
Also, the FDA approval signifies that there is no significant difference in the rate and extent of absorption of the therapeutic ingredient between this new formulation and the original formulation of Opana ER.
Endo added that the U.S. Patent and Trademark Office will issue patent number 8,075,872 on Dec. 13. The patent covers the new formulation of Opana ER and is expected to provide protection until November 2023.
