US-based healthcare company, Endo Health Solutions has completed its transition of OPANA ER franchise to the new formulation designed to be crush resistant. In connection with the completion of this transition, the US Food and Drug Administration (FDA) has moved the old formulation of OPANA ER to the Orange Book Discontinued List.
“While the original formulation of OPANA ER was deemed by FDA to be safe and effective when taken according to the prescribing information, the original formulation was subject to both intentional and inadvertent abuse and misuse,” said Dr Ivan Gergel, chief scientific officer of Endo. “Patient safety is our top concern and addressing appropriate use of opioids is a responsibility that we take very seriously. We firmly believe that the 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.”
As a result of the FDA placing OPANA ER (NDA 21-610) in the Orange Book Discontinued List, all strengths of the original formulation of OPANA ER are now on the Discontinued List. The OPANA ER (NDA 21-610) 7.5 mg and 15 mg dosage strengths were moved to the Discontinued List previously. The new formulation of OPANA ER designed to be crush resistant (under NDA 201655) remains on the approved prescription drug product list as it is the only currently available formulation.
Endo Health Solutions Inc. (Endo) is a diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology.