AcelRx Pharmaceuticals announced that patents have been approved for “Bioadhesive Drug Formulations for Oral Transmucosal Delivery,” and “Bioadhesive Drug Formulations for Oral Transmucosal Delivery.” The issued patents will provide intellectual property protection for a bioadhesive tablet for oral transmucosal administration of sufentanil through January 2027. AcelRx exclusively owns both patents.
“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 first patent provides protection in the United States for each of AcelRx’s four development programs. It also covers AcelRx’s proprietary NanoTab technology for delivering sufentanil with claims to a substantially homogenous bioadhesive tablet 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 second patent also covers the composition of sufentanil NanoTabs with claims to a bioadhesive tablet for sublingual administration to a subject wherein the bioadhesive material is present at between 2% and 30% by weight, and the tablet generates a minimal saliva response and minimal swallowed drug and delivers at least 55% of the sufentanil through the oral transmucosal route.
Other means to protecting the intellectual property include U.S. patents which claim both methods and compositions directed to sufentanil containing NanoTabs. There is also European patent protection which covers small-volume NanoTab dosage forms for transmucosal administration containing the opioid sufentanil and elements of AcelRx’s dispensing technology and provides patent protection of specific pharmacokinetic parameters derived from sublingual administration using the NanoTab technology. Additionally, AcelRx currently has more than 70 pending patent applications worldwide and continues to file additional new patent applications to further strengthen its market exclusivity.
AcelRx Pharmaceuticals 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, 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. This product is currently in Phase 3 clinical trials. AcelRx has two additional product candidates which have completed Phase 2 clinical development and plans to initiate a Phase 2 study, pending protocol approval, for a fourth product.
For additional information about AcelRx’s clinical programs please visit www.acelrx.com
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