Non-opioid analgesic meloxicam rejected by US FDA

25 May 2018

Shares of US drugmaker Recro Pharma (Nasdaq: REPH) collapsed on Thursday, falling over 50%, as the non-opioid analgesic specialist said its application to market meloxicam as an intravenous pain relief treatment had been rejected by the US regulator.

Investors had had high hopes for the therapy, after the firm released positive Phase III data in 2016 supporting its safety and efficacy.

The Complete Response Letter (CRL) from the US Food and Drug Administration stated that, “although the outcome of the pivotal Phase III trials demonstrated statistically-significant outcomes on the primary endpoints, the FDA is unable to approve the application in its current form.”

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