09:01 ACRX (from Briefing.com)
AcelRx: Canaccord Genuity reviews this morning's clinical results announcement; NDA remains on track (6.40)
Canaccord notes ACRX reported that it has achieved its primary endpoint (SPID-48) for its placebo-controlled Phase 3 study in major orthopedic surgery (knee or hip replacement) for its sublingual Sufentanil NanoTab PCA System. This is the third (of a total of three) Phase 3 studies the Co has completed, and NDA submission remains on track for Q3 2013. Firm continues to see an attractive market opportunity for ARX-01 in the hospital setting, with un-risk adjusted peak sales of $577 mln in 2022. The study enrolled 426 adult patients at 34 US sites and showed a significantly greater SPID-48 versus placebo-treated patients (+76.1 vs -11.5, p<0.001) while also hitting secondary endpoints.
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