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
TheStreet Open House

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.

(Logo:  http://photos.prnewswire.com/prnh/20130226/MM67303LOGO)

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

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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 17,055.87 -116.81 -0.68%
S&P 500 1,982.77 -11.52 -0.58%
NASDAQ 4,508.6880 -19.0010 -0.42%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs