SAN FRANCISCO, CA--(Marketwired - July 14, 2016) - Oxycodone is a powerful and lucrative painkiller, but one with serious downsides. Dependency on the opioid has become a major issue medically, politically and, most profoundly, for the patients whose addictions have become debilitating or fatal. DURECT Corp.'s Remoxy, an abuse-deterrent formulation of oxycodone, has an FDA approval date of Sept. 25, 2016, and may provide a safer alternative.
Included in this article is: DURECT Corp. (
Rodman and Renshaw analyst Raghuram Selvaraju, in a research report issued July 5, noted the FDA has decided not to hold an Advisory Committee (AdCom) meeting for DURECT Corp.'s Remoxy, and to retain the Sept. 25 Prescription Drug User Fee Act (PDUFA) date.
"We believe this suggests that the efficacy and safety profile of Remoxy has been well presented in the NDA (new drug application) package, from the FDA's perspective...therefore, in our view, Remoxy is likely to secure regulatory approval in September," Selvaraju wrote.
Continue reading this article: DURECT's Abuse-Deterrent Opioid Poised for FDA Approval
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