AcelRx Pharmaceuticals, Inc. (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) has issued AcelRx two Notices of Allowance for the patent applications entitled "Small-Volume Oral Transmucosal Dosage Forms" and "Bioadhesive Drug Formulations for Oral Transmucosal Delivery." The patents to be issued from these applications describe a method of treating pain by adhering a small-volume solid tablet containing sufentanil to the oral mucosa, as well as compositions and dosage forms broadly covering NanoTab formulations. The patents to be issued can be kept in force for sufentanil NanoTab based products through at least February of 2029.
A related European patent, EP2114383B1, was previously issued by the European Patent Office (EPO) in June 2010 and AcelRx is also prosecuting similar claims internationally through the Patent Cooperation Treaty (PCT).
"These are important additions to our patent portfolio and strengthen our ability to protect our proprietary technology as we advance clinical development of the ARX-01 sublingual sufentanil PCA system for management of moderate to severe acute pain in the hospital setting," said Richard King, AcelRx's President and CEO. Mr. King added, "We are focused on continued expansion of our patent portfolio as we further investigate the safety and efficacy profile of our sublingual sufentanil NanoTabs."
These allowances issued by the USPTO are in relation to sublingual sufentanil NanoTabs. AcelRx exclusively owns the underlying patent applications, which when issued will individually and collectively provide domestic protection for each of the Company's four development programs. The 11/650,174 patent application covers AcelRx's proprietary NanoTab technology for delivering sufentanil with claims to a method for treating pain by adhering a small volume (3-15 mcL) 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. The 11/825,251 patent application contains broad claims to sufentanil-containing bioadhesive tablets up to 50 microliters in volume which generate a minimal saliva response and deliver the majority of the active ingredient through the transmucosal route.
AcelRx also holds a related European patent EP2114383, 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 50 pending worldwide patent applications and continues to file additional new patent applications to further strengthen its market exclusivity.
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