AcelRx Pharmaceuticals, Inc. (ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, provided an update on the timing and potential content of the resubmission of the New Drug Application or NDA for Zalviso.
AcelRx late last week received correspondence from the Food and Drug Administration or 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 stated that it 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.
The company noted that the Complete Response Letter or CRL 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 included 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.
ACRX closed Friday's trading at $8.74. In Monday's pre-market trading, the company's shares are down $3.35 or 38.33% to $5.39.
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