What Companies Will This FDA Decision Impact?
The U.S. Food and Drug Administration ruled Friday that a new version of Opana ER, a painkilling drug, does not deter drug abuse better than earlier versions. Companies will be allowed to make generic versions of the older Opana ER, reports The Wall Street Journal.
The case centered around Endo Pharmaceuticals’s (NASDAQ:ENDP) claim that the new version of Opana ER, which they launched in 2012, featured an anti-crush design that would deter abusers from grinding the drug into a powder and either injecting or snorting it.
“We think the public health would not be served if a company can market itself as ‘abuse deterrent,’ if the scientific evidence did not support that claim,” said Douglas Throckmorton, a deputy director in the FDA’s Center for Drug Evaluation and Research.
Had the FDA ruled that the new Opana ER drug was, in fact, more of an abuse deterrent, they could have put a stop to the generic brands being produced by Actavis and Impax.
The precedence of the FDA banning generic versions of painkillers (when more deterrent versions are available) was set when Purdue Pharmaceuticals came out with a new version of OxyContin that was harder for abusers to crush into powder. After FDA approval, generic versions were taken off the market, and Purdue was left to enjoy the fruits of its patented labor.
Pfizer (NYSE:PFE) and Johnson & Johnson (NYSE:JNJ) have been trying to create safer, branded painkillers in the hopes of replicating Purdue’s success. The Opana ER ruling was undeniably a win for them as well, as it left the gate open for the first company to introduce a new version that the FDA rules as abuse-deterrent.