FDA denies request to block generic versions of Opana ER

FDA has denied Endo Health Solutions' petition to block generic forms of its opioid agonist Opana ER, which contains oxymorphone. FDA’s decision comes just weeks after it nixed generic OxyContin and approved abuse-deterrent labeling for reformulated OxyContin (Purdue Pharma).

In 2012, Endo filed a Citizen Petition with FDA, requesting a formal determination of whether its voluntary removal of the original non-tamper-resistant version of Opana ER from the market in 2012 had been done for reasons related to safety (i.e., how easily the product could be crushed, snorted, or otherwise misused). An affirmative ruling would mean that the drug could no longer serve as the basis of an approval of an ANDA (Abbreviated New Drug Application).

Endo’s purpose in presenting the petition was to prevent the marketing and distribution of two new generic forms of Opana ER that FDA had already approved, as well as to pressure FDA to overturn those approvals.

In support of its petition, Endo presented data to FDA that it had collected in an ongoing epidemiology study. The data indicated that for every 100,000 prescriptions dispensed, the past-month abuse rate of crush-resistant Opana ER was 79% lower than the abuse rate of the generic versions of extended-release oxymorphone that went on the market in 2012. 

"Based on these 2 recent decisions, we sense that FDA is setting a standard for how much effectiveness is required from the various tamper-proof mechanisms in order to delay the launch of generic alternatives,” Cynthia Ambres, MD, partner, US member of KPMG’s Global Healthcare Center of Excellence, told Formulary. 

“In the case of Purdue, it appears that they did manage to create a superior form of tamper-resistance that includes resistance to cutting, grinding, chewing, and dissolving for injection, according to the National Association of Boards of Pharmacy,” Dr Ambres said. “This is apparently not the case with Endo's new form of Opana ER, which can still be misused by alteration, according to FDA. If this difference holds true, then there is good reason for one tamper-resistant drug form to be approved over the other. Managed care organizations and providers have always been on the side of patient safety, as well as efficacy and cost, in the management of pain.”