AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today provided an update on the timing and potential content of the resubmission of the New Drug Application ("NDA") for Zalviso.

AcelRx late last week received correspondence from the Food and Drug Administration ("FDA") stating that in addition to the bench testing and two Human Factors studies it has performed, an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures.  AcelRx had previously obtained confirmation from the FDA that the protocol designs for the bench testing evaluating dispensing failures and the Human Factors studies evaluating inadvertent dispensing were acceptable to the FDA.  

AcelRx plans to meet with the FDA to discuss and clarify the agency's belief that an additional clinical study is needed, and the potential design and objectives of such a study. As a result of this FDA communication and the need for clarity with FDA, AcelRx will not be making the Zalviso NDA resubmission this quarter.  AcelRx will provide an update on the timing of the resubmission of the Zalviso NDA after AcelRx obtains more information from the FDA.

For more details, go to: http://news.acelrx.com/phoenix.zhtml?c=241441&p=irol-acelrxnewsArticle&ID=2023704