FDA issues Complete Response Letter to AcelRx Pharmaceuticals for Zalviso System for Acute and Breakthrough Pain
AcelRx Pharmaceuticals, Inc. has announced that the FDA has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso (sufentanil sublingual tablet system) a proposed treatment for Acute and Breakthrough Pain. The Company is currently reviewing the FDA's comments and requests contained in the CRL and plans to discuss these requests with the FDA.
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.
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