AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure. ARX-04 (sufentanil sublingual tablet, 30 mcg) is being developed for the treatment of moderate-to-severe acute pain in adult patients administered by a healthcare professional in a medically supervised setting.
"We appreciate the CHMP's consideration of ARX-04 for regulatory review under the centralized process, which we expect will make our planned MAA filing with the EMA much more efficient," commented Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx. "The EMA's centralized procedure is typically limited to products the EMA believes constitute significant therapeutic, scientific or technical innovations, characteristics we believe ARX-04 possesses."
For eligible drugs, the centralized procedure permits the submission of a single marketing application to the EMA that, if approved, allows the drug to be marketed in all 27 EU member states, as well as in the three European Economic Area (EEA) countries: Iceland, Liechtenstein and Norway.
ARX-04 is currently being studied in an open-label Phase 3 study (SAP302) in adult patients who present in the emergency room with acute moderate-to-severe pain associated with trauma or injury, and an additional Phase 3 study (SAP303) is planned in postoperative patients with acute moderate-to-severe pain. An earlier Phase 3 trial (SAP301) in patients with acute moderate-to-severe pain following ambulatory abdominal surgery demonstrated that patients administered ARX-04 experienced significantly greater pain relief compared to those receiving placebo, as measured by the time-weighted summed pain intensity difference over the first 12 hours of treatment (SPID12) (p<0.001). AcelRx expects to file marketing applications to both the EMA and the U.S. Food and Drug Administration (FDA) for ARX-04.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative sublingual therapies intended for the treatment of acute pain. The company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg) designed for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso™ designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index opioid, sublingually through a disposable, pre-filled, single-dose applicator. AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and has advanced ARX-04 into a study (SAP302) in emergency room patients. In addition, AcelRx intends to initiate SAP303, a study in post-operative patients 40 years of age or older, in the first quarter of 2016. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. In response to the New Drug Application (NDA) AcelRx submitted to the U.S. Food and Drug Administration (FDA) seeking approval for Zalviso, AcelRx received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an additional clinical study and the Company is working with the FDA regarding the resubmission of the Zalviso NDA and initiation of a clinical study to support resubmission.
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, including the process and timing of anticipated future development of Zalviso and ARX-04; anticipated results and timing of the completion of the SAP302 and SAP303 studies for ARX-04; AcelRx's plans to seek a pathway forward towards gaining approval of Zalviso in the United States; and anticipated resubmission of the Zalviso NDA to the FDA, including the scope and timing of resubmission. These forward-looking statements are based on AcelRx's current expectations and inherently involve significant risks and uncertainties. AcelRx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: any delays or inability to obtain and maintain regulatory approval of its product candidates, including Zalviso and ARX-04; its ability to successfully design and complete the additional clinical study requested by the FDA to support resubmission of the Zalviso NDA; its ability to timely resubmit the Zalviso NDA to the FDA and to receive regulatory approval for Zalviso; the fact that the FDA may dispute or interpret differently positive clinical results obtained to date from the pivotal Phase 3 ambulatory surgery study of ARX-04 (SAP301); its ability to complete Phase 3 clinical development of ARX-04; the success, cost and timing of all product development activities and clinical trials, including the SAP302 and SAP303 ARX-04 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 Quarterly Report on Form 10-Q filed with the SEC on November 3, 2015. 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.