AcelRx Pharmaceuticals Receives First U.S. Patent for Small-Volume Oral Transmucosal Dosage Forms

REDWOOD CITY, Calif., June 20, 2012 /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 the U.S. Patent and Trademark Office (USPTO) issued AcelRx Patent Number 8,202,535 entitled "Small-Volume Oral Transmucosal Dosage Forms."  The patent describes a method of treating pain by administering a small-volume solid tablet containing sufentanil by adhering to the oral mucosa.  This newly issued patent will provide intellectual property protection for sufentanil NanoTab based products through late 2030.

"This important addition to our patent portfolio strengthens our ability to protect our proprietary technology in the United States," said Richard King, AcelRx's President and CEO.  "We remain focused on continued expansion of our patent portfolio as we establish the safety and efficacy profile of our ARX-01 Sufentanil NanoTab PCA System, with first data from our Phase 3 program for ARX-01 expected later this year."

This method patent is the first patent the USPTO has issued in relation to sublingual sufentanil NanoTabs.  AcelRx exclusively owns this patent, which provides domestic protection for each of AcelRx's four development programs.  The 8,202,535 patent covers AcelRx's proprietary NanoTab technology for delivering sufentanil with claims to elements of a method for treating pain by administering a small volume (<15mcl) substantially homogenous solid tablet containing the active ingredient sufentanil to the oral mucosa of a subject while generating a minimal saliva response and delivering the majority of the drug through the transmucosal route resulting in consistent pharmacokinetics.

AcelRx also holds a European patent EP2114383B1, which covers small-volume NanoTab dosage forms for transmucosal administration containing the opioid sufentanil. The European patent covers elements of AcelRx's dispensing technology and also provides patent protection of specific pharmacokinetic parameters derived from sublingual administration using the NanoTab technology.  AcelRx currently has more than 70 pending patent applications worldwide and continues to file additional new patent applications to further strengthen its market exclusivity.

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, the ARX-01 Sufentanil NanoTab PCA System, which is currently in Phase 3 clinical development, is designed to solve the problems associated with post-operative intravenous patient-controlled analgesia which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the inherent potential for programming and delivery errors associated with the complexity of infusion pumps.  AcelRx has two additional product candidates which have completed Phase 2 clinical development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office.  A fourth product candidate, ARX-04, is a sufentanil product for the treatment of moderate-to-severe acute pain, and AcelRx plans to initiate a Phase 2 study funded by a grant from USAMRMC, contingent on approval of the proposed clinical protocol for the study by USAMRMC.  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 AcelRx Pharmaceuticals' patent portfolio, including the useful life of the U.S. patent for a method of treating pain by administering a small-volume solid tablet containing sufentanil by adhering to the oral mucosa, the continued expansion of its patent protection, market exclusivity, its ability to protect its proprietary technology, the scope of patent protection, and issued and planned or anticipated future clinical development of AcelRx Pharmaceuticals' product candidates, including the initiation of the third Phase 3 clinical studies for ARX-01, the timing of the top-line data from all three clinical trials, the timing of submission of an NDA with the FDA, and the therapeutic potential of AcelRx Pharmaceuticals' 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 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: the success, cost and timing of AcelRx Pharmaceuticals' product development activities and clinical trials; the success of its patent prosecution strategy; its ability to protect its proprietary technology, including the risks that pending patent applications may not result in issued patents; its ability to obtain sufficient financing to complete development and registration of its product candidates in the United States and Europe; its ability to obtain and maintain regulatory approvals of its product candidates; the market potential for its product candidates; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' U.S. Securities and Exchange Commission filings, including its Annual Report on Form 10-K for the Year ended December 31, 2011 and its Quarterly Report on Form 10-Q for the three months ended March 31, 2012.  AcelRx Pharmaceuticals 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.

SOURCE AcelRx Pharmaceuticals, Inc.