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.
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SOURCE AcelRx Pharmaceuticals, Inc.