Navigation Links
Atlantic Pharmaceuticals, Inc. Announces Completion of Successful Pre-IND Meeting with FDA for Abuse Deterrent Narcotic
Date:6/23/2009

ATLANTA, June 23 /PRNewswire/ -- Atlantic Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that it has completed a pre-investigational new drug (PIND) meeting with the Food and Drug Administration (FDA) for guidance on a mutually acceptable regulatory pathway for submission of an abuse deterrent immediate release oxycodone.

Atlantic's proprietary oral delivery technology Smart/Script(TM) is the basis of the abuse deterrent characteristics of the product. For the currently marketed formulations of commonly misused immediate release opioids, simple methods such as chewing, crushing and/or dissolution in water can expose the entire dose of opioid contained in the formulation, allowing it to be injected or used nasally. Tampering with the dosage form and self-administering it orally, nasally or intravenously results in a rapid rise in the blood concentration of the opioid. A rapid rise in blood concentration is more likely to result in drug liking and reinforcement and increases the abuse liability of the drug. Once a drug is loaded into Smart/Script(TM) however, it is non-extractable in common injectable solutions, non-crushable and is released when activated in the gastrointestinal system.

Anthony Soscia, President of Atlantic, stated, "We appreciate the comprehensive feedback we received from our pre-IND meeting with the FDA. This regulatory direction will assist our application process. We believe this guidance sets our NDA filing target for 2010."

The increasing misuse, abuse and diversion of opioid pain medications have become widespread and pose costly and significant public health issues. In 2005, the estimated total cost associated with opioid abuse, including health care, justice, and work-related costs, totaled $9.5 billion. Commercially, the U.S. pain market alone is currently estimated at $14.5 billion according to Global Industry Analysts, Inc.

About Atlantic Pharmaceuticals

Atlantic Pharmaceuticals, Inc., is a privately held specialty pharmaceutical company dedicated to the discovery and development of innovative, late-stage therapies for substance abuse and pain-related conditions and diseases. Our products target therapeutic opportunities utilizing molecules shown to be safe and effective with formulations that are protected by intellectual property. We believe that our approach will lead to improved patient care, reduced healthcare costs and a rapid time to market. For more information, visit the Company's website at http://www.atlanticpharma.com.

    Contact:

    Anthony Soscia
    Atlantic Pharmaceuticals, Inc.
    Phone: 678.638.6170
    info@atlanticpharma.com

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.


'/>"/>
SOURCE Atlantic Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Frances Decker Named Mid-Atlantic Region Sales Executive for AllOne Health Management Solutions
2. British Council and Los Angeles Area Universities Partner to Host Transatlantic Dialogues
3. Verizon Introduces Broadband Video Call Center Link for Deaf or Hard-of-Hearing Customers in Mid-Atlantic Region
4. Statement by Bonnie J. Campbell, Former Attorney General of Iowa and Spokesperson for Atlantic Richfield Co., Millennium Holdings, LLC, NL Industries, Inc., and The Sherwin-Williams Company on the Jury Verdict Reached Today in the Thomas (Milwaukee) Case
5. HLTH Corporation Sells its Minority Interest in Emdeon Business Services to General Atlantic and Hellman & Friedman for $575 Million
6. General Atlantic and Hellman & Friedman Purchase HLTH Corporations Remaining Interest in Emdeon
7. National Atlantic Holdings Corporation to Report Fourth Quarter and Year-End 2007 Earnings on March 17, 2008
8. Atlantic Street Capital Announces First Close
9. J.D. Power and Associates Study Ranks Kaiser Permanente Highest in Member Satisfaction in South Atlantic Region
10. Z Trim Multifunctional Fiber Lightens the Menu Labeling Legislation Issue at Mid-Atlantic Food Expo, September 17 & 18
11. Advanced Wound Technologies Mid-Atlantic, Inc. Announces Name Change and Reverse Stock Split
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating ... many ways they remain in the eye of the beholder, according to experts who ... of The American Journal of Managed Care. For the full issue, click here ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room ... Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of ...
(Date:6/24/2016)... ... , ... A recent article published June 14 on E Online ... on to state that individuals are now more comfortable seeking to undergo not only ... calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) ...
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
Breaking Medicine Technology: