Navigation Links
Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)

PALATINE, Ill. and BRISTOL, Tenn., July 2 /PRNewswire-FirstCall/ -- Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, USP and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain.

(Logo: )

(Logo: )

The Complete Response Letter raises issues regarding the potential abuse deterrent benefits of Acurox(R). Acura and King are currently evaluating the FDA's Complete Response Letter, and at this stage believe they can respond to the issues raised without conducting any additional studies. The Companies plan to meet with the FDA following submission of their response.

About Acurox Tablets

Acurox is a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate-to-severe pain. Acurox utilizes Acura's proprietary Aversion Technology, which is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets and nasal snorting of crushed tablets. The Acurox(R) Tablets NDA was originally accepted for filing by FDA earlier this year with a priority review classification.

About Acura Pharmaceuticals, Inc.

Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of Aversion(R) (abuse deterrent) Technology product candidates and other innovative abuse deterrent technologies. Acura and King jointly developed Acurox(R) Tablets and are developing three additional opioid analgesic product candidates utilizing Aversion(R) Technology pursuant to a 2007 License, Development and Commercialization Agreement.

About King Pharmaceuticals, Inc.

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company's focus in specialty-driven markets, particularly neuroscience and hospital. King's wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacturing and marketing of pharmaceutical products for food producing animals.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). When used in this press release, the words "estimate," "project," "anticipate," "expect," "intend," "believe," and similar expressions are intended to identify forward-looking statements. Examples of forward looking statements in this press release include statements concerning the Companies' expectations regarding the timing or content of their response to the FDA concerning the Complete Response Letter and the Companies' expectations regarding any meeting with the FDA to discuss the Complete Response Letter. Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. disclaim any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risk factors include, but are not limited to, whether or when the Companies are able to gain FDA approval of the Acurox(R) Tablets NDA; whether additional clinical studies will be required to support FDA approval of the Acurox(R) Tablets NDA; whether or when the Companies may gain FDA approval of product labeling for the proposed indication or for abuse deterrent features; and the benefits of Acurox(R) and the ability of Acurox(R) to deter abuse in actual practice. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of each of the Companies' Annual Reports on Form 10-K for the year ended December 31, 2008 and their respective Quarterly Reports on Form 10-Q for the quarter ended March 31, 2009, each of which is on file with the U.S. Securities and Exchange Commission.

SOURCE King Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
2. Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
3. SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
4. Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE(TM)
5. Cepheid Receives Grant to Develop Ten-Color Real-Time PCR Detection Technology for Use in the GeneXpert(R) System
6. DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD
7. Malaria Vaccine Developer, Sanaria Inc., Receives 2009 Vaccine Industry Excellence Award for Best Early-Stage Vaccine Biotech
8. NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia
9. AMT Receives EMEA Orphan Drug Designation for Acute Intermittent Porphyria
10. Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System
11. Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015 iRhythm Technologies, Inc. , a ... today announced that it will participate in the 27th Annual Piper ... New York, NY . Kevin King , ... December 1, 2015 at 8:50am ET. --> ... . --> . --> iRhythm ...
(Date:11/24/2015)... Ontario , Nov. 24, 2015 Teledyne ... digital X-Ray image sensing technology, will introduce its CMOS ... Technical Exhibition , November 29 to December 3, at McCormick ... of dynamic detectors for diagnostic and interventional imaging will be ... Xineos family of advanced CMOS X-Ray detectors is ...
(Date:11/24/2015)... The uptake of recently approved and pipeline premium products for ... growth to 2021, says GBI Research . ... Type 1 Diabetes Mellitus (T1DM), will be a key driver of market ... --> The uptake of recently approved and pipeline premium products ... market growth to 2021, says GBI Research . ...
Breaking Medicine Technology:
(Date:11/24/2015)... , ... November 24, 2015 , ... It takes only ... a business, it is critical that the first impression be positive and reflects business ... not likely to buy anything or want to return. They will also share their ...
(Date:11/24/2015)... ... 24, 2015 , ... United Benefit Advisors (UBA), the nation’s ... as its newest Partner Firm. Based in Jefferson City, Missouri, their core philosophy ... regardless of whether that client is a business, a family, or an individual. ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Serenity Point Rehabilitation, ... series of recent video interviews with some of the staff members at their recovery ... residential treatment facility, as well as some of the things that make their recovery ...
(Date:11/24/2015)... ... 2015 , ... Abington Hospital – Jefferson Health is pleased ... Surgery Facility for treating individuals living with morbid or extreme obesity. , Aetna ... its members to help them make informed decisions about their healthcare needs. In ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Specialty ... Program have announced their endorsement of the Medical Fitness Network (MFN), a ... proud to have the MFN as one of our endorsed organizations,” said ASH ...
Breaking Medicine News(10 mins):