By RTT News,
July 25, 2014, 10:22:00 PM EDT
(RTTNews.com) - AcelRx Pharmaceuticals, Inc. ( ACRX ) announced late Friday that the U.S. Food and Drug Administration or FDA has issued a Complete Response Letter or CRL for the company's new drug application for Zalviso (sufentanil sublingual tablet system).
The specialty pharmaceutical company focused on the treatment of acute and breakthrough pain said it is currently reviewing the FDA's comments and requests contained in the CRL and plans to discuss these requests with the FDA.
According to the firm, the CRL contains requests for additional information on the Zalviso System to ensure proper use of the device. The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product.
The company added that there were no requests to conduct additional human clinical studies.
Richard King, president and CEO of AcelRx, said, "We believe we can satisfy all of FDA's requests in the CRL and resubmit the NDA by the end of 2014, although we will have more clarity on the process and timing after our conversation with FDA. We are confident in the Zalviso development program and will work closely with the FDA to address the Agency's concerns as outlined in the CRL to ensure that healthcare professionals and patient communities will have access to Zalviso."
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