Pain Therapeutics tanks as FDA issues another CRL for Remoxy ER
US drugmaker Pain Therapeutics (Nasdaq: PTIE) saw its shares plunge as much as 65%, with the stock down 53.8% at $1.26 late morning, after the company revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration on the resubmission of its New Drug Application for Remoxy ER (oxycodone capsules CII).
The CRL informs that Remoxy ER cannot be approved in its present form and specifies additional actions and data that are needed for drug approval. The drug was previously under development with US pharma giant Pfizer (NYSE: PFE), which returned rights to in 2014.
The CRL focuses on the abuse-deterrent properties of Remoxy ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter.
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