Key Developments: Acura Pharmaceuticals Inc (ACUR.O)

ACUR.O on Consolidated Issue listed on NASDAQ Capital Market

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Latest Key Developments (Source: Significant Developments)

Acura Pharmaceuticals Inc submits formal dispute resolution request with FDA regarding Hydrocodone Bitartrate With Acetaminophen Tablets
Monday, 15 Sep 2014 06:00am EDT 

Acura Pharmaceuticals Inc:Says it has submitted a formal dispute resolution request with the FDA for Vycavert, its abuse deterrent formulation of hydrocodone and acetaminophen tablets.The dispute pertains to the FDA's determination that nasal snorting abuse of hydrocodone with acetaminophen products lacks relevance.By taking this action, Acura is availing itself of the FDA's established appeal process whereby disagreements with conclusions reached by a reviewing Division within the FDA are reviewed above the Division level.FDA guidance stipulates that the FDA respond within 30 days.  Full Article

Acura Pharmaceuticals Inc provides update on FDA discussions surrounding development of Aversion Hydrocodone With Acetaminophen Tablet
Friday, 15 Aug 2014 06:15am EDT 

Acura Pharmaceuticals Inc:Says preliminary discussions from meeting held with U.S. Food and Drug Administration (FDA) regarding development pathway for Acura's AVERSION hydrocodone with acetaminophen tablet development candidate.Says which is intended to provide abuse-deterrent features to address abuse by nasal snorting and injection.Says in a May letter to Acura, FDA questioned relevance of abuse of hydrocodone with acetaminophen products by nasal snorting after reviewing clinical and epidemiology data submitted by Acura.Says FDA continues to question the relevance of abuse of hydrocodone with acetaminophen products by the intranasal route of administration and suggested additional information may help better inform their decision.Says FDA indicated in discussions that Acura may conduct additional nasal abuse liability study for its AVERSION hydrocodone with acetaminophen product candidate.Says outcomes of which may help inform relevance decision as well as establish reduction in drug liking, which was not statistically significant in an earlier Acura study (Study AP-ADF-301).Says FDA requested further time to deliberate on the issues discussed during the meeting before issuing final meeting minutes.  Full Article

Acura Pharmaceuticals Inc provides update on its abuse deterrent Hydrocodone/Acetaminophen combination drug
Tuesday, 27 May 2014 05:00pm EDT 

Acura Pharmaceuticals Inc:Says US Food and Drug Administration (FDA) advised Company that data from intranasal abuse liability study AP-ADF-301 (Study 301) for AVERSION hydrocodone bitartrate with acetaminophen (hydrocodone/APAP) product candidate are insufficient to support an intranasal abuse deterrence claim.Study 301 failed to achieve a statistically significant reduction in Drug Liking (also known as Emax).Acura previously submitted report to FDA on prevalence of abusing hydrocodone products by intranasal administration and intends to meet with the FDA to discuss the FDA's expectations in this area.  Full Article

Acura Pharmaceuticals Inc announces settlement of patent litigation with Sandoz Inc
Wednesday, 21 May 2014 04:15pm EDT 

Acura Pharmaceuticals Inc:Enters into Settlement Agreement with Sandoz Inc. to settle Acura's patent infringement action pending against Sandoz in the United States District Court for the District of Delaware.In the suit, Acura alleges that generic of Acura's AVERSION oxycodone product, previously marketed by Pfizer Inc. under its brand name OXECTA.For which Sandoz is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration (FDA) infringes a U.S. patent owned by Acura.Under Sandoz Settlement Agreement, Sandoz may launch its generic to the AVERSION oxycodone product in the U.S., through the grant of a non-exclusive license from Acura to Sandoz.In certain circumstances, Acura's license to Sandoz would become effective prior to such time.  Full Article

Acura Pharmaceuticals Inc announces settlement of patent litigation with Ranbaxy Inc
Thursday, 8 May 2014 06:30am EDT 

Acura Pharmaceuticals Inc:It has entered into settlement agreement with Ranbaxy Inc.To dismiss, without prejudice, its patent infringement action pending against Ranbaxy in US District Court for District of Delaware.Says suit, Acura alleges that generic of Acura's AVERSION oxycodone product, previously marketed by Pfizer Inc.Settlement agreement provides that Ranbaxy's current product that is subject of its ANDA does not infringe Acura's Orange Book listed patents with FDA.Acura has not provided Ranbaxy with license to Acura's patents and Acura may re-commence patent infringement litigation against Ranbaxy if Ranbaxy changes formulation of its generic to AVERSION oxycodone product.  Full Article

Acura Pharmaceuticals announces return of product rights
Wednesday, 9 Apr 2014 08:00pm EDT 

Acura Pharmaceuticals Inc:Says letter agreement with Pfizer Inc. for termination of Pfizer's license to Acura's AVERSION Technology and return to Acura of FDA approved Oxecta (oxycodone HCl) product.Letter agreement provides Acura to make a one-time payment of $2.0 mln to Pfizer.License termination is effective April 9.  Full Article

Acura Pharmaceuticals Inc secures $10 mln debt financing
Monday, 30 Dec 2013 04:10pm EST 

Acura Pharmaceuticals Inc:Says it entered into a Loan and Security Agreement with Oxford Finance LLC, pursuant to which Oxford agreed to make a term loan to the company in the principal amount of $10.0 million.Says the loan has a fixed interest rate of 8.35 percent per annum with interest only payment for the first 15 months and repayment of all principal and interest by Dec. 1, 2018.Says In addition, at maturity or earlier termination, the company must pay Oxford an additional one-time interest payment of $795,000.  Full Article

Acura Pharmaceuticals Inc says FDA to review data from failed painkiller trial - Reuters
Monday, 9 Dec 2013 06:49am EST 

Acura Pharmaceuticals Inc:Says U.S. Food and Drug Administration agreed to review the results of a failed mid-stage trial of a painkiller made with the company's technology designed to deter abuse - Reuters.Says results from the mid-stage trial showed in Aug. that Acura's tablet, being tested for potential abuse by snorting, did not reduce likability among abusers.Says on Dec. 09 FDA agreed to provide a definitive response regarding the suitability of the trial to be considered in an approval application review.  Full Article

Acura Pharmaceuticals Inc Announces Settlement of Oxecta Patent Litigation With Par Pharmaceutical and Impax Laboratories Inc
Wednesday, 9 Oct 2013 04:10pm EDT 

Acura Pharmaceuticals Inc announced that it has entered into distinct Settlement Agreements with each of Par Pharmaceutical and Impax Laboratories Inc, to settle Acura's patent infringement action pending against them in the United States District Court for the District of Delaware. In the suit, Acura alleges that a generic Oxecta product for which each of Par and Impax is separately seeking approval to market in the United States pursuant to an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration (FDA) infringes a U.S. patent owned by Acura. Par is the first filer of an ANDA for a generic Oxecta product and is entitled to the 180-day first filer exclusivity under applicable law and FDA regulations. Under the terms of the Settlement Agreement with Par, Par may launch its generic Oxecta product in the U.S., through the grant of a non-exclusive, royalty-bearing license from Acura to Par that would trigger on January 1, 2022. Par is required to pay Acura royalties in the range of 10% to 15% of Par's net profits from the sale of its generic Oxecta product. Under the Settlement Agreement, Impax may launch its generic Oxecta product in the U.S., through the grant of a non-exclusive, royalty-free license from Acura to Impax that would trigger 180 days following the first sale of a generic Oxecta product in the U.S. by an entity that is entitled to the 180 day first-filer exclusivity under applicable law and FDA regulations.  Full Article

Acura Pharmaceuticals Inc Submits Investigational New Drug Application
Thursday, 20 Dec 2012 08:00am EST 

Acura Pharmaceuticals Inc announced that Investigational New Drug application (IND) has been filed with the U.S. Food and Drug Administration (FDA) to allow clinical testing of Acura's hydrocodone bitartrate with acetaminophen formulated with Aversion Technology. Clinical testing can commence under the IND 30 days following the IND filing unless questions are raised by the FDA. An open IND is required for Acura to initiate intranasal abuse liability testing in recreational drug users of the crushed drug product.  Full Article

FDA seeks more data on Acura's abuse-resistant pain drug

- Acura Pharmaceuticals Inc said the U.S. Food and Drug Administration (FDA) indicated that the company may have to conduct an additional study to determine the abuse-deterrent capability of its experimental painkiller treatment.

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