The FDA has pushed back King Pharmaceuticals (KG) and Acura Pharmaceuticals (ACUR) June 30 PDUFA date for Acurox, the companies’ short-acting oxycodone/niacin pill designed to deter abuse. The news sent ACUR shares down 36% to close at $5.89 for the day.

So what’s going on? Is the FDA getting backed up for the summer and will we see pushbacks for other upcoming dates – DDSS, SPPI, NGSX?

Or, is a complete response in the works?

Analysts were mixed on the issue.

Gary Nachman at Leerink Swann expects an approval early next year, saying:

“We expected a delay for Acurox. I didn’t think that the FDA would be able to check all the boxes they needed to check on this within six months. They’re trying to figure out the whole process of approving abuse-deterrent opioids.”

Corey Davis, an analyst at Natixis Bleichroeder said he was not surprised and still expects an approval in September or October:

“It’s par for the FDA’s course for how they’ve been very cautiously dealing with these abuse-deterrent opioids.”

Meanwhile, Biologic Investment Research analyst Kevin McNamara is more bearish and expects a complete response letter:

“It’s a data and labelling issue. I don’t think they have the data to have an appropriate label. I think they are going to be sitting on an approvable letter for quite a while.”

Hmmm…thoughts?

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