Pain Therapeutics first sought approval for Remoxy in 2008 and then again in 2011. The FDA cited concerns over clinical safety, drug efficacy, manufacturing and stability as past reasons for rejection.
This time, the agency said the company needs to perform additional studies to back up proposed label claims about the drug’s abuse-resistant properties.
Pain Therapeutics said it will conduct the necessary studies before submitting Remoxy for approval for the fourth time, according to the report. Company shares fell 54 percent on Monday to $1.24 upon news of the rejection.
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