AcelRx Pharmaceuticals announced today that the U.S. Patent and Trademark Office (USPTO) has issued AcelRx Patent Number 8,202,535, titled “Small-Volume Oral Transmucosal Dosage Forms.” The patent details a method for treating pain by administering a small-volume solid tablet that contains sufentanil by adhering to the oral mucosa. The patent will give intellectual property protection for sufentanil NanoTab-based products until late 2030.
This newly issued patent is an important addition to AcelRx Pharmaceuticals’ patent portfolio, strengthening the company’s ability to protect its proprietary technology in the U.S. The company remains dedicated to the continued expansion of its patent portfolio as it establishes the safety and efficacy profile of the ARX-01 Sufentanil NanoTab PCA System, the first phase 3 data for which is being expected later this year. The system, AcelRx’s lead product candidate, 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 due to the side-effects of morphine, the invasive IV route of delivery, and the inherent potential for programming and delivery errors related to the complexity of infusion pumps.
This newly issued method patent is the first patent issued by the USPTO in relation to sublingual sufentanil NanoTabs. Exclusively owned by AcelRx, the patent provides domestic protection for each of the company’s four development programs. Patent 8,202,535 covers the company’s proprietary NanoTab technology for delivering sufentanil with claims to elements of a pain treatment method by administering a small volume (less than 15mcl) substantially homogenous solid tablet that contains the active ingredient sufentanil to the oral mucosa of a subject, simultaneously generating a minimal saliva response and delivering most of the drug through the transmucosal route, resulting in pharmacokinetics.
AcelRx additionally holds a European patent EP2114383B1, covering small-volume NanoTab dosage forms for transmucosal administration that contains the opioid sufentanil. This European patent covers portions of the company’s dispensing technology and also provides patent protection of particular pharmacokinetic parameters derived from sublingual administration using the NanoTab technology. With more than 70 patent applications currently pending throughout the world, AcelRx continues to file additional new patent applications to further solidify its market exclusivity.
AcelRx Pharmaceuticals is a specialty pharmaceutical company engaged in developing and commercializing innovative therapies for treating acute and breakthrough pain.
For more information, visit the company’s Web site at www.acelrx.com
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