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Sufentanil sublingual tablet system study results to be presented at the International Association for the Study of Pain Meeting

REDWOOD CITY, Calif., Oct. 6, 2014 /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 that a new data analysis from previously reported phase 3 studies evaluating the sufentanil sublingual  tablet system (SSTS) for the treatment of moderate-to-severe acute pain will be presented at the International Association for the Study of Pain (IASP) Meeting in Buenos Aires, Argentina.   

Brenda Lemus, MD will present results from a phase 3, integrated analysis demonstrating ease-of-use and analgesic onset of the investigational drug/device product compared to IV patient-controlled analgesia (IV PCA).  Patients in all four analyzed age cohorts  (< 45 years, < 65 years, ≥ 65 years and ≥ 75 years) rated SSTS statistically higher than IV PCA for 'Total Ease-of-Care' score, with statistically significant differences in favor of SSTS noted across the following subscales: 'Confidence with Device', 'Ease of Movement', 'Dosing Confidence', 'Pain Control' and 'Knowledge/Understanding'.  The integrated analysis additionally yielded statistically significant onset of analgesia differences in favor of SSTS over IV PCA as measured by pain intensity reduction from baseline, a common outcome variable.  The findings were consistent at all time points from 45 minutes through 6 hours, at which time the scores equilibrated between the two therapies.  In general, adverse events across all treatment arms were mild to moderate in severity with comparable rates of occurrences.

Details of the two presentations are as follows:

Title: "Analgesic Onset of Sublingual Sufentanil Tablet System Compared to IV Patient-Controlled Analgesia – A Phase 3 Integrated Analysis"

Presenter: 

Brenda Lemus, MD

Date:         

Friday, October 10, 2014

Time:          

9:30am-10:30am local time

Location:     

Exhibit Hall, La Rural Congress and Exhibition Center, Buenos Aires, Argentina.

 

Title: "Sufentanil Sublingual Tablet System Ease of Use for Different Age Groups Compared to IV Patient-Controlled Analgesia"

Presenter: 

Brenda Lemus, MD

Date:         

Friday, October 10, 2014

Time:          

3:15pm-4:15pm local time

Location:     

Exhibit Hall, La Rural Congress and Exhibition Center, Buenos Aires, Argentina.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain.  AcelRx's lead product candidate, Zalviso, is designed to improve the management of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. AcelRx has announced positive results from each of the three completed Phase 3 clinical trials for Zalviso, and has submitted an NDA to the FDA seeking approval for Zalviso in the treatment of moderate-to-severe acute pain in adult patients in the hospital setting and on July 25th, received a Complete Response Letter from the FDA.  AcelRx plans to initiate a Phase 3 clinical trial for ARX-04, a product candidate for the treatment of moderate-to-severe acute pain in a medically supervised setting, by the end of 2014. The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development.  For additional information about AcelRx's clinical programs, please visit www.acelrx.com.

AcelRx logo.

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SOURCE AcelRx Pharmaceuticals, Inc.

Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com, or Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com