*FDA decision on Acura Pharma's immediate release opioid analgesic NDA on June 17
Opioid analgesics, which are used for relief of severe or chronic pain, are one of the most frequently abused prescription medications. These opioid analgesics, also known as narcotic analgesics, are at risk of being abused because they are highly addictive in nature.
According to a federal government survey, the prevalence of prescription pain reliever abuse is second only to marijuana abuse. The findings of the survey also indicate that there has been a dramatic increase in the number of prescriptions filled for opioid pain relievers in recent years. From 1997 to 2007, the milligram per person use of prescription opioids in the U.S. increased 402 percent to 369 milligrams from 74 milligrams. The number of prescriptions for opioids dispensed by retail pharmacies has also increased over the years. The number of prescriptions, which was 174 million in 2000, has grown to 257 million by 2009.
In order to curtail the misprescribing, misuse, and abuse of opioid analgesics, the United States government introduced a multi-agency, multi-pronged master plan last month. The same month (April, 2011), in support of the master plan, the FDA called for a Risk Evaluation and Mitigation Strategy, or REMS, that will apply to all extended-release and long-acting opioid medications.
Some of the FDA-approved opioid analgesics for pain management include, Buprenex, Stadol, Tylenol with codeine, Duragesic, Vicodin, Dilaudid, Dolophine , Astramorph, OxyContin and Darvon.
Prescription opioids can be either immediate-release or extended-release products. Immediate-release opioids work for shorter periods of time. Extended-release opioids are designed to provide a longer period of drug release so that they can be taken less frequently. As recently as January of this year, Abstral, an immediate release opioid, was approved by the FDA to manage breakthrough pain for adults with cancer.
According to market research firm Wolters Kluwer, opioid analgesic are generating sales in excess of $10 billion a year in the US.
Now at the altar, awaiting the FDA decision is Acurox, an immediate release opioid analgesic tablet, developed by Acura Pharmaceuticals Inc. (ACUR). Acurox contains oxycodone HCl as its sole active analgesic ingredient and was licensed to King Pharmaceuticals Inc., in October 2007. King was acquired by Pfizer Inc. (PFE) last October in a deal valued at $3.6 billion and the transaction was completed in March of this year.
In December 2010, Pfizer submitted the NDA for Acurox to the FDA, including a request for priority review classification. The Acurox NDA, which was accepted for filing, was also granted a priority review classification. Accordingly, the regulatory agency is scheduled to announce its decision of whether or not to approve Acurox on June 17, 2011.
The 2007 agreement inked with King Pharma, now a subsidiary of Pfizer, called for the development and commercialization in the United States, Canada, and Mexico (Pfizer Territory) Acurox Tablets, Acuracet Tablets, Vycavert Tablets, and a fourth undisclosed opioid analgesic product candidate utilizing Acura's proprietary Aversion technology. Pfizer has an option to license in the Pfizer Territory certain future opioid analgesic products developed utilizing the Aversion Technology.
Yet another advanced drug candidate of Acura is Acurox with Niacin, which failed to pass muster after FDA review. Acurox with Niacin is an immediate release opioid analgesic tablet with a proposed indication for relief of moderate-to-severe pain.
The NDA for Acurox with Niacin Tablets (oxycodone HCl/niacin) was submitted on December 30, 2008 and was issued a Complete Response Letter by the FDA on June 30, 2009.
In an FDA Advisory Committee meeting held last April to discuss Acurox with Niacin Tablets, the panel members voted that there was no sufficient evidence to support the approval of the NDA for Acurox with Niacin Tablets for the treatment of moderate to severe pain, considering the deterrent effects of niacin and the potential abuse deterrent features specific to Acurox with Niacin Tablets.
In light of the FDA seeking more evidence for the abuse deterrent benefits of niacin in Acurox with Niacin Tablets, Acura and Pfizer conducted an additional oral abuse liability study dubbed Study 114. The companies are continuing to evaluate the results of Study 114 and intend to submit a response to the FDA's June 2009 Complete Response Letter for Acurox with Niacin Tablets.
As of March 31, 2011 Acura received aggregate payments of $58.5 million from Pfizer. Acura is also eligible to receive from Pfizer - a $3.0 million option exercise fee for each future opioid product candidate Pfizer licenses, up to $23 million in regulatory milestone payments for each Pfizer licensed product candidate, including Acurox Tablets, in specific countries in the Pfizer Territory, and a one-time $50 million sales milestone payment upon the first attainment of an aggregate of $750 million in net sales of all licensed products combined in all Pfizer Territories.
Acura has yet to generate any revenues or royalty revenues from product sales. According to a recent SEC filing, at April 27, 2011, Acura had cash and cash equivalents of about $20.7 million, sufficient to fund operations through at least the next 12 months.
Will Acura's pain drug candidate pass the FDA muster with ease or will it experience a regulatory pain? Stay tuned...
Updated on June 20, 2011
On June 20, Pfizer Inc (PFE) and Acura Pharmaceuticals Inc. (ACUR) announced that the FDA has approved their immediate release opioid analgesic OXECT, formerly known as Acurox, for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. OXECT contains oxycodone HCl as its sole active analgesic ingredient.
OXECTA is the first immediate-release oxycodone HCl medicine that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.