FDA, Setbacks

A ‘disoriented’ Pain Therapeutics flips out after FDA rejects appeal on Remoxy

Pain Therapeutics has had the last word on its four-time reject Remoxy — and it’s a bitter one.

After a meeting with the FDA, the biotech says, “we believe we are no closer today to product approval than we were over a year ago” thanks to “shambolic regulations” at the agency.

Its stock $PTIE promptly fell 20%, tumbling further into pennystock lowland.

Remi Barbier

The dispute here centers around how easily Remoxy — an extended release gel formulation of oxycodone — can be abused, at a time the deadly opioid crisis has led to calls for heightened vigilance over approval of new pain drugs.

That concern led an expert panel to vote overwhelmingly against the drug before the FDA handed a formal slapdown.

Contrast that with the solid endorsement AcelRx received for its pain med Dsuvia, which was later approved — triggering vocal criticism from an expert on the committee who accuses the FDA for lacking in transparency.

Pain Therapeutics contended the agency misled the advisory committee with “math errors, material mistakes and misrepresentations,” an allegation that regulators denied in their recent meeting with the company.

Before they go silent about their future plans for the drug, CEO Remi Barbier offered a part-eulogy that’s mostly FDA bashing:

Remoxy remains an odyssey without a homecoming. We had hoped for a fair, neutral and impartial review of the Remoxy data. Instead, we walked out of this meeting feeling a bit disoriented by FDA’s lack of transparency, clarity or helpfulness. It’s a rare occasion when two parties can’t agree on simple math. We can’t work with shambolic regulations. This is not how you win support for innovation.

As previously reported, following a reorganization, the biotech plans to focus its remaining resources on a drug for Alzheimer’s, a disease that has defeated every therapy thrown at it for more than a decade.

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

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