San Diego, CA — 11/09/2017 — An investigation was announced for investors of AcelRx Pharmaceuticals Inc over potential securities laws violations in connection with certain financial statements made by AcelRx Pharmaceuticals.
The investigation by a law firm focuses on whether a series of statements by AcelRx Pharmaceuticals Inc regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
On September 26, 2014, AcelRx Pharmaceuticals Inc provided an update on the plans for the resubmission of the Company's New Drug Application (NDA) for Zalviso™ (sufentanil sublingual tablet system). Among other things, AcelRx Pharmaceuticals Inc said that the timing of the filing of the NDA could be later than the first quarter of 2015 and that theFDA communicated that the planned resubmission will qualify as a Class 2 resubmission with a review period of six months.
On October 1, 2014, a lawsuit was filed against AcelRx Pharmaceuticals Inc over alleged Securities Laws Violations. The plaintiff claims that defendants made allegedly false and/or misleading statements and/or allegedly failed to disclose between December 2, 2013 and September 25, 2014 that the Instructions for Use (IFU) for Zalviso were not designed to adequately address the risk of the inadvertent misplacement of tablets, that AcelRx Pharmaceuticals Inc had not submitted to the U.S. Food and Drug Administration (“FDA”) sufficient data to support the shelf life of the product, and 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 March 9, 2015, AcelRx Pharmaceuticals Inc provided an update on the timing and potential content of the resubmission of the New Drug Application (“NDA”) for Zalviso. AcelRx Pharmaceuticals Inc said that late last week it received correspondence from the Food and Drug Administration (“FDA”) stating that in addition to the bench testing and two Human Factors studies it has performed, an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures.
On May 4, 2015, a news reports stated that AcelRx Pharmaceuticals Inc said a division of the FDA had rejected the company's request for a meeting to discuss the need for an additional trial of its pain drug device, Zalvizo.
On October 12, 2017, AcelRx Pharmaceuticals Inc advised investors that the Company had received a complete response letter from the U.S. Food and Drug Administration (“FDA”) regarding AcelRx's New Drug Application for DSUVIA for the treatment of moderate-to-severe acute pain. The FDA requested the collection of additional data on “at least 50 patients to assess the safety of DSUVIA” and recommended certain changes to the Directions for Use to address use-related errors.
Those who purchased shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) have certain options and should contact the Shareholders Foundation.
Shareholders Foundation, Inc.
3111 Camino Del Rio North – Suite 423
92108 San Diego
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