REDWOOD CITY, Calif.,
Oct. 22, 2014 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced
that results from the IAP310 study have been published in
Regional Anesthesia and Pain Medicine (RAPM), a
peer-reviewed journal with broad, multidisciplinary readership.
IAP310 was a randomized, placebo-controlled, Phase 3 trial
evaluating the safety and efficacy of Zalviso, also referred to as
the sufentanil sublingual tablet system (SSTS), for the treatment
of post-operative pain in patients following open abdominal
surgery. Zalviso is an investigational patient-controlled
analgesia drug/device candidate currently under review by the Food
and Drug Administration (FDA). The study met its primary
endpoint, demonstrating that Zalviso was significantly better at
managing pain over 48 hours as measured by Summed Pain Intensity
Difference to Baseline (SPID-48), than placebo (p=0.001).
Zalviso-treated patients had pain scores that separated from
placebo-treated patients within 1 hour after study
initiation. The IAP310 study results had been previously
reported, however this publication represents the first time the
results have been included in a peer-reviewed journal.
Treatment-related adverse events were similar between the two
groups, with fewer Zalviso patients dropping out of the study due
to inadequate analgesia compared to placebo (17.4% vs 31.8%;
p=0.035) and using approximately half as much rescue morphine over
the duration of the trial (1.8 doses vs. 3.8 doses). As a
secondary endpoint, a validated ease-of-care questionnaire was
administered to patients and healthcare providers. Both groups gave
Zalviso a total overall rating above 4.0 on a scale of 0-5.
The authors conclude that Zalviso may integrate well with a
multimodal approach to acute pain management in the hospital
setting.
The manuscript titled 'Sufentanil Sublingual Tablet System for
the Management of Postoperative Pain Following Open Abdominal
Surgery: A Randomized, Placebo-Controlled Study" is available to
read in full online.
Link to view article:
http://journals.lww.com/rapm/Abstract/onlinefirst/Sufentanil_Sublingual_Tablet_System_for_the.99572.aspx
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.