Boston, MA 09/30/2014 (wallstreetpr) – According to reports, AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) has reported the regulatory updates on Zalviso. The main focus of ACRX is on developing and commercializing various innovative therapies and treatment techniques for breakthrough and acute pain. The company is going to resubmit its new drug application (NDA) for Zalviso shortly, for which it has decided to release an update.
Insights of the matter:
Recently AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) held a teleconference call with a few representatives of Food and Drug Administration in order to review the Complete Response Letter of Zalviso, which was received on July 25, 2014. The management of ACRX was so keen to get FDA’s response, and that’s the main reason it proposed FDA to review CRL of Zalviso. It didn’t want to leave any stone unturned; hence, it sent a briefing document to FDA just before the teleconference in order to ensure smooth discussion. FDA representatives provided preliminary comments on the briefing document instantly.
The teleconference went fine, and AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) received good feedback from FDA about protocols, human factors study and bench testing. The company is looking forward to making all the corrections suggested by FDA and resubmit the NDA of Zalviso in the first quarter of 2015. Reporters got in touch with FDA representatives who said that the proposed resubmission would be considered as the class2 resubmission and would carry a review period of six months. Both the parties discussed about various things such as required changes to the Instructions for Use, testing of the mitigations to reduce the incidence of optical system errors and submission of additional data to support the product. After the teleconference, AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) announced that it would acquire bench testing as the perfect approach to evaluating the reduction in OCRs. It would not submit the protocol for the bench testing to FDA for comment and review.
