According to the law firm press release, AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. The Company plans to commercialize its product candidates in the United States and license the development and commercialization rights to its product candidates for sale outside of the United States through strategic partnerships and collaborations. One such product is Zalviso, which consists of sufentanil tablets delivered by the Zalviso System, a needle-free, handheld, patient-administered, pain management system (collectively, “Zalviso”).
The Complaint alleges that defendants made false and/or misleading statements and/or failed to disclose during the Class Period: (1) that the Instructions for Use (IFU) for Zalviso were not designed to adequately address the risk of the inadvertent misplacement of tablets; (2) that the Company had not submitted to the FDA sufficient data to support the shelf life of the product; and (3) that, as a result of the foregoing, Defendants’ statements about Zalviso, including the drug’s regulatory approval and financial prospects, were materially false and misleading at all relevant times and/or lacked a reasonable basis.
On July 25, 2014, after the market closed, AcelRx announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding its New Drug Application for Zalviso. According to the Company, the FDA requested additional information on the Zalviso System to ensure proper use of the device, including changes to the Instructions for Use for the device and additional data to support the shelf life of the product. On this news, shares of AcelRx declined $4.44 per share, nearly 41%, to close on July 28, 2014, at $6.39 per share, on unusually heavy volume.
On September 26, 2014, AcelRx revealed that the resubmission process for its Zalviso NDA would not be complete until the first quarter of 2015 at the earliest. According to the Company, the FDA also communicated that the planned resubmission will qualify as a Class 2 resubmission with a review period of six months. On this news, shares of AcelRx declined $1.31 per share, over 19%, to close on September 26, 2014, at $5.41 per share, on unusually heavy volume.
This case was dismissed with prejudice on January 18, 2016.