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FDA provides a long-delayed OK for KemPharm’s opioid — with strings attached

Twenty months after the FDA shot down KemPharm’s application for its powerful opioid Apadaz, regulators have come through with a long delayed green light for the company to start marketing the pain therapy.

The drug is an immediate release combo of benzhydrocodone and acetaminophen, and it’s to be used for no more than 14 days at a time for acute pain that can’t be managed by any of the alternatives.

KenPharm’s shares surged 13% on the back of the approval Friday afternoon.

KemPharm $KMPH was able to get a thumbs up from an expert group of FDA advisers in early 2016 — at least as far as its effect on pain. The biotech had also sought an OK to sell their opioid as abuse deterrent, but a big majority of the experts refused to go that far.

Travis Mickle

Researchers argued that the opioid was activated by enzymes in the intestinal tract would be difficult to get high off of by snorting, injecting or smoking it. But the agency shot back that it was distinctly alarmed by its potential for abuse, particularly by snorting the drug.

The biotech’s statement on the approval adds that the DEA plans to schedule Apadaz as a C-II controlled product, with specific rules on prescribing it.

That’s a big issue these days, as lawmakers have raised repeated outcries over the epidemic of opioid abuse in the US.

“The approval of Apadaz is a significant milestone for KemPharm as it creates the opportunity to introduce what we believe is a differentiated product for the short-term management of acute pain,” said KemPharm CEO Travis Mickle.  “Based on its unique properties, we firmly believe there is a commercial pathway for Apadaz in what is a very high-volume market.”

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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