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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.

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