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ACUR Submits an NDA for ACUROX Tablets
publication date: Dec 21, 2010
On Monday Acura Pharmaceuticals quietly announced the submission of a New Drug Application for its ACUROX (oxycodone) tablets. Within this request they filed for priority review classification. Lets take a look at what this means for ACUR and its share price.
First off, what is Acurox?
Acurox® is an immediate release opioid analgesic tablet with a proposed indication for relief of moderate-to-severe pain and is designed to deter common methods of misuse and abuse. Acurox® Tablets are being developed in strengths of 5mg and 7.5mg.
The FDA had told the company in July 2009 that the agency would not approve the drug but agreed to seek input from the advisory panel, a group of outside experts. ACUR has had a rough stretch over the past few months after and FDA advisory Panel voted 19-1 against the approval for Acurox. The FDA praised the company for trying to thwart drug abusers, but had a problem with the inclusion of niacin in the drug. Dr. Bob Rappaport, head of the FDA division reviewing Acurox said "if they come back with a different set of data we'll probably come back to the committee."
Take a look at the chart for ACUR:
As mentioned above, yesterday ACUR announced the filing of an NDA (New Drug Application) with the FDA for a reformulated version of Acurox. Per their press release:
"King has submitted a New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. Food and Drug Administration (FDA), including a request for priority review classification. ACUROX® is an immediate release tablet containing oxycodone HCl intended for the relief of moderate to severe pain. ACUROX® utilizes Acura's patented Aversion® Technology which is designed to deter opioid abuse by intravenous injection of dissolved tablets and nasal snorting of crushed tablets. ACUROX® does not contain niacin. A separate NDA submission for ACUROX® with Niacin Tablets is subject to an FDA Complete Response Letter. Further details on the response to this FDA action letter will be provided at a later date.
The FDA is expected to determine whether to accept the NDA for ACUROX® for filing and consider the priority review request within 60 days."
The FDA is obligated to accept the NDA filing or return a RTF (Refusal to File) letter within 60 days. This catalyst has triggered a frenzy of trading activity, spiking shares up to $3.95 this morning, up over 34% from yesterday's close at $2.94. We alerted our purchases this morning at $2.95 via the private BioRunUpTrades Twitter feed and via SMS alert.
Disclosure: Long ACUR