/PRNewswire/ -- AcelRx Pharmaceuticals, Inc., 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 recently issued AcelRx Patent Number 8,252,328 entitled "Bioadhesive Drug Formulations for Oral Transmucosal Delivery," and Patent Number 8,252,329 also entitled "Bioadhesive Drug Formulations for Oral Transmucosal Delivery." The '328 and '329 patents each make claims to a bioadhesive tablet for oral transmucosal administration of sufentanil. These newly issued patents will provide intellectual property protection for sufentanil NanoTab based products until at least January 5, 2027. AcelRx currently has more than 70 pending patent applications worldwide and continues to file additional new patent applications to further strengthen its market exclusivity.
"We have made significant progress this year in establishing our intellectual property portfolio, with five issued US patents now underpinning our novel NanoTab technology," said Richard King, AcelRx's President and CEO. "We look forward to building on this success through emphasis on the device aspects of our technology platforms as we seek multiple avenues of protection for our proprietary pipeline of product candidates."
The 8,252,328 patent is a composition of matter patent which provides protection in the United States for each of AcelRx's four development programs. The '328 patent covers AcelRx's proprietary NanoTab technology for delivering sufentanil with claims to a substantially homogenous bioadhesive tablet, comprising from about 2.5 to about 100 micrograms of sufentanil and a volume of from about 3 to about 15 microliters, which adheres throughout the period of drug delivery, generates a minimal saliva response and delivers a majority of the drug through the oral mucosa.
The 8,252,329 patent also covers the composition of sufentanil NanoTabs with claims to a bioadhesive tablet for sublingual administration to a subject, comprising from about 2.5 micrograms to about 100 micrograms of sufentanil, a volume of about 0.1 microliters to about 50 microliters, wherein the bioadhesive material is present at between 2 percent and 30 percent by weight, and the tablet generates a minimal saliva response and minimal swallowed drug and delivers at least 55 percent of the sufentanil through the oral transmucosal route. AcelRx exclusively owns both of these patents.
AcelRx also holds three other U.S. patents which claim both methods and compositions directed to sufentanil containing NanoTabs. Collectively these patents will provide intellectual property protection for sufentanil NanoTab based products in the United States through late 2030. European patent protection is provided by Patent Number EP2114383B1, which covers small-volume NanoTab dosage forms for transmucosal administration containing the opioid sufentanil. This European patent also covers elements of AcelRx's dispensing technology and provides patent protection of specific pharmacokinetic parameters derived from sublingual administration using the NanoTab technology.