This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

AcelRx Top-line Data Show Primary Endpoint Achieved In Pivotal Phase 3 Study Of Sufentanil NanoTab PCA System For Post-Operative Pain In Major Open Abdominal Surgery Patients

REDWOOD CITY, Calif., March 4, 2013 /PRNewswire/ -- 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 results demonstrating that the first of two pivotal placebo-controlled Phase 3 studies for its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint.  Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups.


The primary endpoint evaluated pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery.  Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (p=0.001).  Secondary endpoint data also showed that 24 hours and 72 hours after first dose, SPID was significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 and p=0.004 respectively).     

"These favorable results enable AcelRx to continue moving forward towards submission of a New Drug Application (NDA) for the Sufentanil NanoTab PCA System in the third quarter of this year," said Richard King, president and CEO of AcelRx.  "In the weeks ahead, our team will work with the FDA to complete a pre-NDA meeting in support of this goal."

Phase 3 Study ResultsUtilizing a randomized, double-blind, placebo-controlled design, this pivotal Phase 3 study enrolled 178 adult patients at 13 U.S. sites for the treatment of acute post-operative pain immediately following major abdominal surgery.  Patients were treated for post-operative pain for a minimum of 48 hours, and up to 72 hours.  Patients were randomized 2:1, with 119 patients randomized to sufentanil and 59 to placebo treatment.  Both treatments were delivered by the patient, as needed, using the NanoTab System with a 20-minute lock-out period.  Patients in both groups could receive up to 2 mg morphine intravenously per hour as a rescue medication, the primary purpose of this rescue medication being to provide placebo-treated patients access to pain medication to enable them to stay in the study as long as possible.  Pre-rescue pain scores were imputed to minimize the impact of this rescue opioid on efficacy evaluations.

Eighty, or 70.2% of the sufentanil NanoTab-treated patients completed the 48-hour study period, compared to 30 (51.7%) placebo-treated patients.  Reasons for drop-out in the sufentanil- and placebo-treated groups were adverse events (5.3% and 6.9% respectively), lack of efficacy (16.7% and 31.0% respectively) and other (7.9% and 10.3% respectively).  The primary endpoint measure, SPID-48, was 105.6 for sufentanil-treated patients and 55.6 for placebo-treated patients (p=0.001). 

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 18,077.51 -2.63 -0.01%
S&P 500 2,114.27 -3.42 -0.16%
NASDAQ 5,070.4930 -21.5920 -0.42%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs