TooNiceStocks Initiates Coverage On Acura Pharmaceuticals Inc. Pending June 17th, 2011 FDA Decision With Elevated Interest
TooNiceStocks research has uncovered a near term catalyst for Acura Pharmaceuticals, Inc. On February 14th, 2011, the FDA accepted the NDA for Acura’s lead product, Acurox. The drug was granted a priority review with a PDUFA (Prescription Drug User Fee Act) date of June 17th, 2011. To add to the excitement, TooNiceStocks research further found that Acura is also in the final stages of negotiations with its preferred contract manufacturer to scale up, manufacture and market its Impede PSE product in hopes of being able to sell it directly to distributors without having to file a new drug application. In TooNiceStocks opinion, a potentially huge savings in time and money.
Acura Pharmaceuticals primary focus is the design, manufacture and sale of drugs containing active ingredients that are often abused by addicts. However, with their proprietary formulations with ingredients that impede abuse they hope to garner the FDA’s support in approving a broader spectrum of products. Additionally, they plan to use their technology to manufacture or license out their technology to other manufactures as a huge value added to the company. Acura anticipates and is hopeful Acurox will be approved in June, which will not only impact the immediate financials of the company, but it would also help legitimize their drug-deterrent technology. In TooNicestocks opinion, would likely open doors to other drugs being administered via the same technology.
Digging Deeper into the product and its potential.
Acurox contains oxycodone HCl, a very commonly prescribed narcotic pain reliever that is widely abused. TooNiceStocks research found the approximate number of emergency department (ED) episodes involving oxycodone was stable in the early 1990′s. However, the numbers increased remarkably from 3,190 cases in 1996 with to 10,825 cases in 2000. Abuse from the drug usually comes from dissolving the pills in a solution to extract the active ingredients and injecting the liquid or from crushing the pills and snorting the powder. Acurox attempts to address both issues.
TooNiceStocks dug deeper and found that Acura’s other major plan (if Acurox approval comes) for 2011 is that of marketing another product, Impede PSE. It contains the active ingredient, pseudoephedrine hydrochloride (commonly marketed as Sudafed), which is a common over the counter drug approved for nasal congestion associated with the common cold and other ailments. However, it is commonly converted by illegal means into methamphetamine. Therefore, it is now sold “behind the counter” with purchasers being required to present identification and have their purchases of the drug tracked and regulated per the Federal Combat Methamphetamine Epidemic Act. Alternative, but less effective decongestants have been developed such as phenylephrine. Similar to the Acurox application, Impede PSE addresses the solubility and therefore extraction issue that would be required to remove the pseudoephedrine from the crushed pills in order to convert it to an illicit drug. Using what are believed to be the three most common means of extracting the active ingredient from the decongestant, Acura analyzed Impede PSE versus Sudafed. Acura’s hope with Impede PSE is not only to market and sell the drug, but also to do such without having to file a new drug application to the FDA and go through the expensive and time-consuming regulatory process that comes with it. Acura hopes their 30mg Impede PSE tablet will meet the FDA’s requirements for “Over-the-Counter Human Drugs Which are Generally Recognized as Safe and Effective and Not Misbranded” as indicated in the Code of Federal Regulations at 21CFR330.1.
TooNiceStocks sees a future with Acura’s patented technologies and hopes their technology along with others, will help combat illicit drug use in the United States and beyond. On the other hand, TooNiceStocks also found that the July 2nd, 2009 complete response letter for another version of Acurox, with Niacin for the same indication, has not as of yet been fully addressed. Additionally, as impressive as the results are for Study PR-382 was this time around, this is just one study involving one chemist, thus more data may be required from a similar or larger study. Acurox, designed with safety in mind to prevent abuse of its active ingredients may require additional trials not only to confirm the results, but to look at the long-term effects of the drug depending on what the composition of the inactive ingredients are. Many uncertainties and unknowns cloud around FDA biotech decisions. However one thing is certain, the run up or rally for Acura Pharmaceuticals Inc. is kicking off and may last into the the week of June 17, 2011 catalyst date. Remember this is the market, anything can happen.
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