CRL from FDA for Pain Therapeutics' Remoxy ER

6 August 2018

Pain Therapeutics has received a Complete Response Letter from the US Food and Drug Administration for its New Drug Application (NDA) for the abuse-deterrent opioid drug Remoxy ER (oxycodone) extended-release capsules CII.

News of the CRL sent Pain Therapeutic’s shares plunging 40.37% to $1.44 by late morning trading.

The CRL concluded that "the data submitted in [the] NDA do not support the conclusion that the benefits of [Remoxy] extended-release capsules outweigh the risks."

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