Navigation Links
AcelRx Pharmaceuticals Receives Fourth and Fifth U.S. Patents for Small-Volume Oral Transmucosal Dosage Forms
Date:8/29/2012

REDWOOD CITY, Calif., Aug. 29, 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) 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% 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. 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.  

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. 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, which is currently in Phase 3 clinical development, 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.  AcelRx has two additional product candidates which have completed Phase 2 clinical development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office.   AcelRx plans to initiate a Phase 2 study, pending protocol approval, for a fourth product candidate, ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, funded through a grant from USAMRMC.  For additional information about AcelRx's clinical programs please visit www.acelrx.com.

Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to AcelRx Pharmaceuticals' patent portfolio, including the useful life of its U.S. patents and the European patent, the continued expansion of its patent protection, market exclusivity, its ability to protect its proprietary technology, the scope of patent protection, and issued and planned or anticipated future clinical development of AcelRx Pharmaceuticals' product candidates, including the execution of the Phase 3 clinical studies for ARX-01,  the initiation of Phase 2 clinical trial for ARX-04, and the therapeutic potential of AcelRx Pharmaceuticals' product candidates.  These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.  AcelRx Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of AcelRx Pharmaceuticals' product development activities and clinical trials; the success of its patent prosecution strategy; its ability to protect its proprietary technology, including the risks that pending patent applications may not result in issued patents; its ability to obtain sufficient financing to complete development and registration of its product candidates in the United States and Europe; its ability to obtain and maintain regulatory approvals of its product candidates; the market potential for its product candidates; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' U.S. Securities and Exchange Commission filings, including its Quarterly Report on Form 10-Q for the three months ended June 30, 2012.  AcelRx Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.


'/>"/>
SOURCE AcelRx Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. AcelRx Pharmaceuticals Reports First Quarter 2012 Financial Results
2. AcelRx Pharmaceuticals Announces Pricing of a $10.0 Million PIPE Financing
3. AcelRx Pharmaceuticals, Inc. to Webcast, Live, at RetailInvestorConferences.com on July 12th
4. AcelRx Pharmaceuticals, Inc. Investor Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com
5. AcelRx Pharmaceuticals Receives Two Additional U.S. Patents for Small-Volume Oral Transmucosal Dosage Forms
6. AcelRx Pharmaceuticals to Hold Second Quarter 2012 Financial Results Conference Call and Webcast on August 9, 2012
7. AcelRx Pharmaceuticals to Present at the Canaccord Genuity 32nd Annual Healthcare Conference
8. AcelRx Pharmaceuticals Reports Second Quarter 2012 Financial Results
9. AcelRx Pharmaceuticals to Present at Three Upcoming Investor Conferences
10. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
11. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... Research and Markets has announced the addition of the ... Market and Increasing Usage of Complex Biologics during the Forecast Period" ... ... 20 Billion in 2015 to around USD 26 Billion by 2020. ... by Rapidly Expanding Injectables Market and Increasing Usage of Complex Biologics ...
(Date:4/20/2017)... April 20, 2017  AbbVie (NYSE: ABBV), a ... (n=145/146) of chronic hepatitis C virus (HCV) infected ... 6 and compensated cirrhosis (Child-Pugh A) achieved sustained ... ) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir ... seen following 12 weeks of G/P treatment without ...
(Date:4/20/2017)... , April 20, 2017 NeuroVive ... ("NeuroVive") today announced positive preclinical results demonstrating ... compound for non-alcoholic steatohepatitis (NASH), in an ... NV556 has previously shown similar ... model. Today, NeuroVive,s scientists present novel data ...
Breaking Medicine Technology:
(Date:4/25/2017)... ... 2017 , ... ProRehab Physical Therapy (PRPT) is ... therapy provider for Derby City CrossFit, effective immediately. , In addition to treating ... effectively as possible, ProRehab’s sports physical therapists will work with athletes to maximize ...
(Date:4/25/2017)... ... 2017 , ... A recent report from the Wisconsin Institute ... 2015-16 school year across Wisconsin’s public schools, charter schools, and private schools participating ... student test score performance, the report’s limited analyses fail to provide answers as ...
(Date:4/25/2017)... , ... April 25, 2017 , ... ... they rely on contracted partners to help with process innovation in drug formulation ... drug formulation experience along with state-of-the-art analytical equipment in support of their development ...
(Date:4/25/2017)... ... 25, 2017 , ... Saad B. Chaudhary, MD is committed to providing the highest quality of ... I focus on preventative care with all my patients to alleviate possible future issues. I ... free to contact my office and my trained staff will assist you in any way ...
(Date:4/25/2017)... ... 25, 2017 , ... Vetoquinol USA® , a world-class ... part of the EQUISTRO line, at this week’s Rolex Kentucky Three-Day Event in ... immunologic level. , The scientifically-developed Flexadin UCII supports the body’s normal repair of ...
Breaking Medicine News(10 mins):