May 19, 2015 (Update) - 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. Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) declined on May 13, 2015 to as low as $2.96 per share.

March 16, 2015, (Update) - 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. Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) declined to as low as $3.91 per share on March 16, 2015.

August 4, 2014 (Shareholders Foundation) - An investigation on behalf of investors of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) shares over potential securities laws violations by AcelRx Pharmaceuticals and certain of its directors and officers in connection certain financial statements was announced.

The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) concerning whether a series of statements by AcelRx Pharmaceuticals regarding its business, its prospects and its operations were materially false and misleading at the time they were made.

AcelRx Pharmaceuticals Inc reported that its annual Total Revenue rose from $$2.39 million in 2012 to $29.50 million in 2013 and that its respective Net Loss declined from $33.36 million to $23.43 million. Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) grew from $3.01 per share in November 2012 to as high as $12.69 per share in early 2014.

Then on July 25, 2014, AcelRx Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Company's new drug application (NDA) for Zalviso (sufentanil sublingual tablet system). The Company is currently reviewing the FDA's comments and requests contained in the CRL and plans to discuss these requests with the FDA. AcelRx Pharmaceuticals said that the Complete Response Letter contains requests for additional information on the Zalviso System to ensure proper use of the device. AcelRx Pharmaceuticals said that additional bench testing will be required and human factors testing may be required to address certain items in the Complete Response Letter.

Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) dropped from as high as $11.38 per share during July 25, 2014, to as low as $6.11 per share on July 28, 2014.