Robbins Umeda LLP
today announced that a class action has been commenced in the United States District Court for the Northern District of Illinois (the "Court") on behalf of purchasers of Acura Pharmaceuticals, Inc. ("Acura" or the "Company") (NASDAQ: ACUR) common stock during the period between February 21, 2006 and April 22, 2010.
Acura engages in the research, development, and manufacture of pharmaceutical product candidates utilizing its proprietary Aversion Technology and other technologies. Acura claims its Aversion Technology is a proprietary platform technology providing abuse deterrent features and benefits to orally administered pharmaceutical drug products containing abusable active ingredients, such as tranquilizers, stimulants, sedatives, decongestants, and various other opioid analgesics. The Company states that its lead product candidate, Acurox Tablet ("Acurox"), is an orally administered immediate release tablet containing oxycodone HCl as its active analgesic ingredient. Acura was founded in 1935 and is based in Palatine, Illinois.
The complaint alleges that Acura and certain of its officers concealed material adverse facts concerning the effectiveness of Acurox. Additionally, the complaint charges Acura and certain of its officers with violations of the Securities Exchange Act of 1934.
According to the complaint, the Company failed to disclose material information regarding Acurox, including: (i) its clinical data was defective and its clinical studies were not properly designed; (ii) Acura had wholly ignored specific directives from the U.S. Food and Drug Administration (the "FDA") over the past four years as to specific clinical trials and evidence Acura had to demonstrate; and (iii) no evidence had ever been presented to the FDA that the niacin addictive discouraged abusers from abusing oxycodone.
Then, on April 20, 2010, the FDA announced that the Company's clinical data and studies were substandard. Upon this news, Acura's stock price declined 42.5% in one day, to close at $6.25 in afterhours trading. Further, on April 22, 2010, the FDA Joint Panel voted nineteen to one against approving Acurox, and it was reported that the FDA had been prodding Acura to demonstrate the deterrent efficacy of niacin since at least May 2009. As a result of these disclosures, the Company's stock price declined an additional 39%, to $3.20 per share, in the pre-market trading on April 23, 2010.