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Acura Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript

The lead development product, hydrocodone with acetaminophen has demonstrated bioequivalence to its reference drug and the development plan discussed with the FDA at a pre-IND meeting is generally comparable to the development plan used for OXECTA. We will work with Pfizer to in effect an appropriate transition of the development products back to Acura within the next 12 months. Once we have the products back, we will be in a position to assess our strategic options for them, including the potential to relicense them to a motivated partner for development and commercialization. Pfizer has impressive marketing capabilities that have the potential to make OXECTA a long-term success.

However, we believe that their decision to price OXECTA at such a significant premium to the market has been a hindrance to the initial uptake of this product. Even so, we remain hopeful that their continued efforts position OXECTA as part of the solution to combat the abuse and misuse of opioids will soon be evidenced in not only the sales of OXECTA, but also may benefit our other AVERSION opioid products as well.

The problem of prescription opioid abuse persists. Two recent New York Times articles provided anecdotal information that abusers of extended-release opioids may be shifting to other drugs, including immediate release opioids when faced with tamper-resistant products. The Centers for Disease Control and Prevention estimates 1 person dies every 19 minutes from prescription drug abuse in the United States. We are encouraged by the fact that state and national lawmakers are devoting more attention to this epidemic and proposing legislation to combat the issue.

Importantly, last month, a bipartisan group of congressmen, led by Representative William Keating of Massachusetts, introduced the Stop Tampering of Prescription Pills Act of 2012, otherwise known as the STOPP Act. If approved, the STOPP Act would provide a framework for defining tamper-resistant technologies and encourage the development and adoption of tamper-resistant opioids. This legislation has the potential to initiate a dialogue between physicians, regulators, third-party payers and others concerned with the epidemic of prescription opioid abuse and misuse to promote the proper use of tamper-resistant technologies, along with other risk mitigation strategies.

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