Acura Pharmaceuticals, Inc. (NASDAQ:ACUR), announced that it is initiating development of an immediate-release hydrocodone bitartrate with acetaminophen tablet (“hydrocodone/APAP”) incorporating Acura’s novel LIMITX™ abuse deterrent technology. Hydrocodone/APAP, with over 135 million dispensed prescriptions in 2014 in the United States, is the largest prescribed opioid to treat moderate to severe pain. It also is the single most abused prescription opioid, predominately by swallowing multiple tablets. LIMITX is designed specifically to address this route of abuse.
The Food and Drug Administration’s (FDA) April 2015 Abuse-Deterrent Opioids Evaluation and Labeling Guidance singles out immediate-release combination opioids with acetaminophen as being predominately abused by the oral route and that reducing nasal snorting of these products may not be meaningful. Development of the Company’s LIMITX technology is currently being supported by a grant from the National Institute on Drug Abuse of the National Institutes of Health (NIH) to develop an immediate-release hydromorphone tablet. The Company intends to initiate formulation development of the LIMITX hydrocodone/APAP tablet upon the conclusion of formulation optimization of the LIMITX hydromorphone product. Acura had previously advanced the development of a hydrocodone/APAP product using our AVERSION® technology, which was designed to deter nasal snorting, but intends to indefinitely suspend those efforts.
“Based on the recent FDA Guidance as well as comments made by the former-FDA Commissioner at a March 2015 Appropriation Hearing, we believe the best course for Acura is to develop immediate-release acetaminophen combination opioids with our novel LIMITX technology”, said Bob Jones, President and CEO of Acura. “We are pleased to be partnered with the NIH on our LIMITX technology and believe it may also be applicable to snorting abuse, which we continue to believe is a route of abuse for these products that needs addressing.” (Original Source)
Shares of Acura closed today at $0.83, up $0.0396 or 5.01%. ACUR has a 1-year high of $1.45 and a 1-year low of $0.41. The stock’s 50-day moving average is $0.74 and it’s 200-day moving average is $0.61.
On the ratings front, Acura has been the subject of a number of recent research reports. In a report issued on February 27, MLV & Co. analyst Vernon Bernardino maintained a Hold rating on ACUR, with a price target of $1, which represents a potential upside of 26.6% from where the stock is currently trading. Separately, on January 9, Roth Capital’s Ed Arce reiterated a Buy rating on the stock and has the same price target of $1.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Ed Arce have a total average return of -10.5% and 33.5% respectively. Bernardino has a success rate of 30.0% and is ranked #3497 out of 3571 analysts, while Arce has a success rate of 44.6% and is ranked #136.
Acura Pharmaceuticals Inc is a pharmaceutical company. It is engaged in the research, development & manufacture of productto address medication abuse & misuse, utilizing the Company’s proprietary, tamper-resistant AVERSION& IMPEDEtechnology platforms.