SOURCE: Streetwise Reports

Streetwise Reports

July 14, 2016 14:37 ET

DURECT's Abuse-Deterrent Opioid Poised for FDA Approval

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. (NASDAQ: DRRX)

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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The following companies mentioned in the article are sponsors of Streetwise Reports: DURECT Corp. Streetwise Reports does not accept stock in exchange for its services. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. The following companies mentioned in the article are sponsors of Streetwise Reports: DURECT Corp. Streetwise Reports does not accept stock in exchange for its services. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

Matt Hogan, CFO of DURECT Corp., was not paid by Streetwise Reports for providing commentary in this article. Comments and opinions expressed are his own comments and opinions. He had the opportunity to review the article for accuracy and is responsible for his comments therein.

Raghuram Selvaraju: Neither I, nor any member of my family, own any shares of the following companies mentioned in this article: None. Neither I personally, nor any member of my family, are paid by the following companies mentioned in this article: None. My company does not own any shares of any companies mentioned in this article, nor has my company performed investment banking services for any of the companies mentioned in this article. I was not paid by Streetwise Reports for providing commentary in this article. Comments and opinions expressed are my own comments and opinions. I had the opportunity to review the article for accuracy and am responsible for my comments therein.

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