Recro Pharma’s Non-Opioid Pain Shot Fails to Get Approval from FDA

May 30, 2018 • By Reuters Staff

(Reuters)—Recro Pharma’s IV meloxicam, a non-opioid injection, did not get approval from the U.S. Food and Drug Administration because the agency said the drug’s pain-relieving effect did not meet its expectations.

The company said it plans to meet with the FDA to find solutions.

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Unlike the drug’s oral version, which has been on the market for several years, Recro’s intravenous formulation is long-acting for treating acute pain, particularly in patients who have undergone surgery.

In a so-called complete response letter, the FDA noted that although late-stage trials of the drug showed statistically significant outcomes on their main goals, it was unable to approve the marketing application in its current form.

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Data from ad hoc analyses and selective secondary goals in the trials suggest that the pain-relieving effect of the drug did not meet expectations, the letter added.

The letter also raised questions on certain other data provided in the company’s application, Recro said.

 

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The Rheumatologist - https://www.the-rheumatologist.org/article/recro-pharmas-non-opioid-pain-shot-fails-to-get-approval-from-fda/

Filed Under: Drug Updates Tagged With: fails approval, meloxicam, non-opioid pain shot, Recro Pharma

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