King Pharmaceuticals and Acura Pharmaceuticals Enter Agreement to Develop and Commercialize Immediate Release Pain Medicines Utilizing Acura's Aversion(R) (Abuse-Deterrent) ...(nd Drug Administration ( FDA ) or Acura'...),Health

Date:10/31/2007

nd Drug Administration ("FDA") or Acura's demonstration of certain stability and pharmacokinetic characteristics for each future product. All products developed pursuant to the Agreement will be manufactured by King or a third party contract manufacturer under the direction of King. Subject to the Agreement, King will have final decision making authority with respect to all development and commercialization activities for all products licensed.

The Agreement closing is subject to antitrust review under the Hart-Scott- Rodino Antitrust Improvements Act.

The United States Patent and Trademark Office has granted U.S. Patent No. 7,201,920 relating to Acura's Aversion(R) (abuse-deterrent) Technology, which expires on March 16, 2025.

About ACUROX(TM) Tablets

ACUROX(TM) (formerly OxyADF) is an orally administered immediate release tablet containing oxycodone HCl as an active analgesic ingredient, niacin as an active ingredient in subtherapeutic amounts, and a unique combination of other ingredients. ACUROX(TM) Tablets are intended to effectively treat moderate to moderately severe pain while discouraging the three most common methods of prescription drug abuse including (i) intravenous injection of dissolved tablets, (ii) nasal snorting of crushed tablets and (iii) intentional swallowing of excessive numbers of tablets.

Earlier this year, Acura reached agreement with the FDA on a Special Protocol Assessment for a pivotal Phase 3 clinical trial evaluating ACUROX(TM) Tablets. This clinical trial is a randomized, double-blind, placebo- controlled, multi-center, repeat-dose study evaluating the safety and efficacy of ACUROX(TM) Tablets for the treatment of acute, moderate to moderately severe postoperative pain. The 3-arm clinical trial compares two dose levels of ACUROX(TM) Tablets to placebo and is targeted to enroll 135 patients per arm (approximately 405 patients in total). Study medication will be administered to patients every six hours for
'/>"/>

SOURCE King Pharmaceuticals, Inc.; Acura Pharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6
Related medicine news :

1. Supply of Radiopharmaceuticals Hampered by Attacks
2. FDA approves Watson Pharmaceuticals Oxytrol patch
3. Ranbaxy Pharmaceuticals Inc awarded the prestigious outstanding supplier award received from Wal-Mart
4. Antigenics Pharmaceuticals plans for Phase III trial of its Melanoma vaccine
5. United Kingdom Is Lagging In Novelty In The Field Of Pharmaceuticals
6. Top Pharmaceuticals Influence Doctors Prescriptions
7. More Study On Side Effects of ADHD Drug Needed: Shire Pharmaceuticals
8. Personalized Medicine and Innovative Pharmaceuticals
9. New lease of life for asthmatics by Accentia Biopharmaceuticals
10. Pravastatin Launched by Watson Pharmaceuticals
11. Tata Industries picks up stake in Indigene Pharmaceuticals