0001144204-14-073689.txt : 20141212 0001144204-14-073689.hdr.sgml : 20141212 20141212161049 ACCESSION NUMBER: 0001144204-14-073689 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20141210 ITEM INFORMATION: Other Events FILED AS OF DATE: 20141212 DATE AS OF CHANGE: 20141212 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ACURA PHARMACEUTICALS, INC CENTRAL INDEX KEY: 0000786947 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 110853640 STATE OF INCORPORATION: NY FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-10113 FILM NUMBER: 141283768 BUSINESS ADDRESS: STREET 1: 616 N. NORTH COURT, SUITE 120 CITY: PALATINE STATE: IL ZIP: 60067 BUSINESS PHONE: 847-705-7709 MAIL ADDRESS: STREET 1: 616 N. NORTH COURT, SUITE 120 STREET 2: . CITY: PALATINE STATE: IL ZIP: 60067 FORMER COMPANY: FORMER CONFORMED NAME: HALSEY DRUG CO INC/NEW DATE OF NAME CHANGE: 19920703 8-K 1 v396420_8k.htm 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D. C. 20549

____________

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act Of 1934

 

December 10, 2014

Date of Report (Date of earliest event reported)

___________________________________________________________

 

ACURA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Charter)

___________________________________________________________

 

State of New York  1-10113  11-0853640
(State of Other Jurisdiction  (Commission File Number)  (I.R.S. Employer
of Incorporation)     Identification Number)

 

616 N. North Court, Suite 120

Palatine, Illinois 60067

(Address of principal executive offices) (Zip Code)

 

(847) 705-7709

(Registrant’s telephone number, including area code)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17CFR240.14d- 2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e- 4(c))

 

 
 

 

Item 8.01Other Events

 

In August 2014, Purdue Pharma L.P. (“Purdue”) announced that it has submitted a New Drug Application (“NDA”), presumably under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) for an immediate-release (“IR”) oxycodone hydrochloride formulation designed with the intent to deter intranasal and intravenous abuse of the medication.

 

On December 10, 2014 we filed a Citizen Petition with the United States Food and Drug Administration (“FDA”) requesting that the FDA require that Purdue file its drug application in a manner citing our Aversion® oxycodone hydrochloride product (formerly known as OXECTA) as a reference listed drug with certifications to the patents related to our Aversion oxycodone hydrochloride product listed in the FDA’s Orange Book.

 

If the FDA grants the relief we are seeking in the Citizen Petition and Purdue is required to provide the certifications required under 21 U.S.C §355(b)(2)(A) or §355(j)(2)(A)(vii), as applicable, of the FD&C Act, with respect to our patents listed in the FDA’s Orange Book for our Aversion oxycodone hydrochloride product, Purdue must certify that it will not market its product before the expiry of our patents, or that our patents are invalid or will not be infringed by Purdue’s product (a “Paragraph IV Certification”). If Purdue were to submit such a Paragraph IV Certification it must promptly give us notice. A Paragraph IV Certification would vest in us important statutory rights, including the right to bring an infringement action against Purdue within 45 days of receiving notice of the Paragraph IV Certification, and the FDA is statutorily prohibited from approving Purdue’s application until 30 months have passed, our patents have expired, or a court has found our patents invalid or not infringed. There can be no assurance that the FDA will grant the relief we are seeking in the Citizen Petition.

 

 
 

  

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  ACURA PHARMACEUTICALS, INC.  
       
       
  By: /s/ Peter A. Clemens  
    Peter A. Clemens  
    Senior Vice President & Chief Financial Officer
       
Date:   December 12, 2014