FDA overrides adcomm, shoots down KemPharm’s opioid

FDA

A little more than a month ago a large majority of members of an FDA advisory committee had no problem waving through a new opioid pain drug from KemPharm. But today the biotech says that the agency has decided to slam the door shut on a marketing approval for Apadaz--at least for now.

KemPharm ($KMPH) had started out with high hopes of getting the panel and the agency to agree to label the drug as abuse deterrent, arguing that an opioid that could only be activated by enzymes in the intestinal tract would be difficult to get high off of by snorting, injecting or smoking it. The outside experts signed off on its analgesic effect, but were left unimpressed by the data provided on abuse deterrence.

By 16 to 4, the panelists concluded that the opioid Apadaz, a prodrug of hydrocodone and benzoic acid combined with acetaminophen, should get a green light. But by 18 to 2 they shot down a question added at the 11th hour, concluding that the drug should not be labeled as abuse deterrent.

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Evidently the FDA insiders were even less impressed, issuing its complete response letter. The company gave no hint about what the FDA will require them to do to get the CRL reversed and the pain drug on the market.

The rejection comes at a time that the opioid epidemic has become a central issue in communities across the country. Today a new study from Johns Hopkins noted that more than half of the people taking an opioid end up setting some aside to share or use later. And that is contributing to an epidemic that has roiled the nation and put all opioids under an intense spotlight. In many ways, this is a bad time to try to introduce a rival that can't be considered abuse deterrent.

“We are currently evaluating the points raised in the CRL and intend to request an End of Review meeting with the Agency to determine the pathway forward for Apadaz,” noted KemPharm CEO Travis Mickle in a prepared statement.

- here's the release

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