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