AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), dipped -35.01% and is now trading at $5.68, hitting new 52-week low of $5.07.
According to PRNewswire, Today, AcelRx Pharmaceuticals, Inc. (ACRX), a specialty pharmaceutical corporation focused on the development and commercialization of innovative therapies for the treatment of acute pain, offered an update on the timing and potential content of the resubmission of the New Drug Application for Zalviso.
AcelRx late last week received correspondence from the Food and Drug Administration 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 formerly 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 talk about 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.
The Complete Response Letter received by AcelRx in July 2014 in response to the Zalviso NDA contained requests for additional information on the Zalviso System to ensure proper use of the device. The requests comprised of provision of data demonstrating a reduction in the incidence of system errors, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. In the CRL, there were no requests to conduct additional human clinical studies. The CRL specifically identified Human Factors studies as appropriate to assess the changes to the instructions for use for the device.
Conference Call:
AcelRx will conduct a conference call and webcast recently, March 9, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to talk about this update, its financial results and program updates. To listen to the conference call, dial in about ten minutes before the planned call to 1-866-361-2335 for domestic callers, 1-855-669-9657 for Canadian callers, or 1-412-902-4204 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors section of the corporation’s website at www.acelrx.com and selecting the Webcast link for the Q4 2014 earnings conference call.
Moreover, According to 24/7 Wall Street, the update was not good for the corporation, as the U.S. Food and Drug Administration (FDA) is requesting an additional clinical study to assess Zalviso. The NDA had been formerly rejected in July of 2014.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical corporation focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx’s lead product candidate, Zalviso, is designed to improve the administration of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device.
