Acura (NASDAQ:ACUR) and King (NASDAQ:KG) expected to meet with FDA January 31

Acurox (containing a combination of oxycodone HCL ad niacin) is a drug that – through the use of Aversion Technology – aims to alleviate moderate and severe pain, and to prevent various misuse and abuse techniques (such as injection of tablets into the veins, taking crushed tablets through the nose, and consuming excess tablets through the mouth). This drug has been co-developed by Acura Pharmaceuticals, Inc. (NASDAQ:ACUR) and King Pharmaceuticals, Inc. (NASDAQ:KG). On January 2, 2009, the companies submitted the New Drug Application (NDA) to the United States of America’s toughest regulator the Food and Drug Administration to get the regulator’s approval to market Acurox. The companies also sent an application requesting priority review from the FDA. Under the Prescription Drug User Fee Act, the FDA had 60 days to review the application and to determine whether the submitted NDA contained sufficient information that would allow it to be accepted for filing. And the FDA did respond within due time. On March 3, 2009, Acura Pharmaceuticals and King Pharmaceuticals announced the NDA of Acurox have been accepted for filing with a Priority Review Classification. The regulator handed the companies a Prescription Drug User Fee Act goal date (also known as Action date or just PDUFA date) of June 30, 2009. This was the date on which the FDA must respond to the companies’ NDA. On July 2, 2009, the companies disclosed the Complete Response Letter that they received from the FDA. Through the letter, the Food and Drug Administration expressed several concerns it had regarding the “potential abuse deterrent benefits of Acurox”. On September 3, 2009, Acura and King announced that they are going to hold a meeting with the Food and Drug Administration to talk about the Complete Response Letter. The meeting is supposed to happen as early as possible in 2010. The most probable meeting date is January 31, 2010.

@@CalendarRight@@ In the meeting, the companies Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc., plan to show proofs of “potential abuse deterrent benefits of Acurox” in front of an Advisory Committee of the Food and Drug Administration. The companies did not invest on another clinical study on Acurox after getting FDA’s Complete Response letter on July 2, 2009. This is because the FDA – in the Complete Response Letter – mentioned that it did not need results of any other clinical study on Acurox.

Acurox is a “patented, orally administered, immediate release tablet containing oxycodone HCL as its sole active analgesic with a proposed indication for the relief of moderate to severe pain”. The drug also prevents many forms of misuse and abuse. If Acurox gets approved by the FDA, it would be the first “immediate release opioid analgesic” that can prevent the misuse and abuse of drugs. The drug makes use of the Aversion Technology, which is under the ownership of Acura Pharmaceuticals Inc. due to License, Development and Commercialization Agreement achieved in 2007. Both Acura Pharmaceuticals and King Pharmaceuticals are specialty pharmaceutical companies that research, develop, manufacture and then market prescription pharmaceutical drugs.