AcelRx Pharma (ACRX) Stock Higher; Sufentanil NanoTab Study Meets Primary Endpoint
- Market Wrap: Zimmer's Big Deal; Durable Orders Up...and Away!; UPS Slips on Winter Chill
- After-Hours Stock Movers 4/24: (CLH) (MKTO) (BIDU) Higher; (CAMP) (P) (CLF) Lower (more...)
- Microsoft Corp. (MSFT) Tops Q3 EPS by 5c
- Amazon.com, Inc. (AMZN) Reports In-Line Q1 EPS, Sales Beat
- Baidu.com (BIDU) Tops Q1 EPS by 25c; Issues Q2 Revs Outlook
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced top-line data demonstrating that in a placebo-controlled Phase 3 study of its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System (NanoTab System), the primary efficacy endpoint was achieved. The study evaluated control of pain intensity compared to baseline during the 48-hour study period immediately following major orthopedic surgery, specifically knee or hip replacement, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline (i.e. SPID-48). Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (+76.1 vs -11.5, p<0.001). Secondary endpoint data showed that SPID at 24 hours and 72 hours was also significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 in each case). Adverse events reported in the study were generally mild or moderate in nature and were similar in both placebo and treatment groups for the majority of adverse events.
You May Also Be Interested In
- Neptune Tech (NEPT) Granted New U.S. Continuation Patet for Alzheimer's Treatment
- Catyalyst Pharma (CPRX) Initiates Expanded Access Program for Firdapse
- Plug Power (PLUG) Files 15M Common Stock Shelf
Create E-mail Alert Related CategoriesCorporate News, FDA, Trader Talk
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!