AcelRx Pharma Provides Update On Zalviso - Quick Facts

(RTTNews) - AcelRx Pharmaceuticals, Inc. (ACRX) said it has provided an update on the plans for the resubmission of the company's New Drug Application or NDA for Zalviso.

The company recently held a teleconference with representatives from the Food and Drug Administration or FDA to review its proposed response to the Zalviso Complete Response Letter received on July 25, 2014.

The company said that before the teleconference, it had submitted a Briefing Document to the FDA and received preliminary comments from the FDA on the Briefing Document.

Based on the communications with the FDA, subject to the timing of the FDA review and comment on protocols to be submitted for the bench testing and Human Factors Study, the company said it is targeting resubmission of the Zalviso NDA in the first quarter of 2015.

According to the company, depending on feedback from the FDA, the timing of the filing of the NDA could be later than the first quarter of 2015 and the FDA also communicated that the planned resubmission will qualify as a Class 2 resubmission with a review period of six months.

The company also stated that during the teleconference with the FDA, it discussed the items included in the CRL, specifically testing of the proposed mitigations to reduce the incidence of optical system errors, changes to the Instructions for Use or IFU for the Zalviso System to address risk of inadvertent misplacement of tablets, and submission of additional data to support the shelf life of the product.

As a result of the communications, the company confirmed that bench testing would be an acceptable approach to evaluate the reduction in optical system errors. The protocol for the bench testing will be submitted to the FDA for review and comment.