REDWOOD CITY, Calif., April 13, 2017 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced that Grunenthal, the company’s licensee for ZALVISO® in Europe and Australia, has published two analyses of patient-controlled analgesia (PCA) systems in the peer-reviewed journal, Current Medical Research and Opinion. These manuscripts were based on a systematic literature review of efficacy, safety and tolerability results from studies that were published between 2004 and 2015 of three routes of PCA administration: intravenous (IV) PCA with morphine, transdermal PCA with fentanyl and sublingual sufentanil delivered via ZALVISO. Patients enrolled in these studies had moderate-to-severe acute post-operative pain following surgical procedures such as knee or hip replacement, open abdominal, cardiac, brain, lower limb orthopedic and chest surgery.
“We know that severe pain after surgery contributes to the development of chronic pain. It is therefore critical that post-operative acute pain is addressed so that patients may regain mobility, which may in turn facilitate their recovery, reduce length of stay and lessen the risk of complications,” commented Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx and a co-author on the Current Medical Research and Opinion papers. “While the analyses in these two papers were conducted via literature review and therefore convey only indirect findings, the conclusions may still be useful to healthcare providers in their assessment of patient-controlled analgesia options.”
Details on the publications:
Katz P, Takyar S, Palmer P, Liedgens H. Indirect treatment comparison of two non-invasive patient-controlled analgesia treatments for acute post-operative pain management. Curr Med Res Opin. 2017 Mar 15:1-8.
Katz P, Takyar S, Palmer P, Liedgens H. Sublingual, transdermal and intravenous patient-controlled analgesia for acute post-operative pain: systematic literature review and mixed treatment comparison. Curr Med Res Opin. 2017 Mar 20:1-12.
About the Journal:
Current Medical Research and Opinion (CMRO) is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. The aim of CMRO is to provide ethical, unbiased quality content that is validated by rigorous peer review. CMRO aims to serve the information needs of the clinical medicine community, to help translate medical advances into patient care and be a leader in transparency and disclosure by facilitating a collaborative and honest approach to publication.
About ZALVISO® (Sufentanil Sublingual Tablet System)
ZALVISO is a drug/device combination product designed to deliver 15 mcg sufentanil, a high therapeutic index opioid, formulated in a proprietary non-invasive sublingual dosage form via a novel hand-held, pre-programmed, patient-controlled analgesia system. ZALVISO is approved in the European Union where a commercial launch has begun by Grunenthal Group GmbH, AcelRx’s licensee for Europe and Australia. ZALVISO remains an investigational product candidate in the United States, where it is currently being assessed in the Phase 3 IAP312 study, which will collect information on device usability, as well as the incidence of misplaced or dropped tablets.
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 moderate-to-severe acute pain. A New Drug Application (NDA) for DSUVIA (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, has been accepted for filing by the FDA in the United States. In the EU, the European Medicines Agency (EMA) has notified the Company that the ARX-04 (sufentanil sublingual tablet, 30 mcg) Marketing Authorisation Application (MAA) has passed validation, and that the scientific review of the MAA is underway.
The Company’s follow on product candidate, ZALVISO® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting, is currently enrolling patients in a Phase 3 clinical trial, IAP312. ZALVISO delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. ZALVISO is approved in the EU and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has begun.
For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx’s product candidates, DSUVIA (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO® (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; the potential approval of the DSUVIA NDA by the FDA; the the European Medicines Agency (EMA) scientific review of the ARX-04 Marketing Authorisation Application (MAA); the DSUVIA and ARX-04 clinical trial results; AcelRx’s pathway forward towards gaining approval of ZALVISO in the U.S., including successful completion of the IAP312 clinical study for ZALVISO; and the therapeutic and commercial potential of AcelRx’s product candidates. These forward-looking statements are based on AcelRx Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals’ DSUVIA and ARX-04 development programs, including the FDA review of the DSUVIA NDA and the EMA review of the ARX-04 MAA, including possibility that the FDA or EMA may dispute or interpret differently clinical results obtained from the DSUVIA or ARX-04 Phase 2 and 3 studies; the ZALVISO development program, including successful completion of IAP312 and the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process; the success and timing of all development activities and clinical trials; and other risks detailed in the “Risk Factors” and elsewhere in AcelRx’s U.S. Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-K filed with the SEC on March 3, 2017. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
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SOURCE AcelRx Pharmaceuticals, Inc.
