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:2/12/2016)... Appleton, Wis. (PRWEB) , ... February 12, 2016 ... ... its second Lean Leadership Series at Zuckerberg San Francisco General Hospital on April ... to practice new behaviors and create new habits. The workshops cover a broad ...
(Date:2/12/2016)... ... 2016 , ... AssureVest Insurance Group, a locally owned insurance firm with offices ... raise funds earmarked to purchase computers and software for Mrs. Harrison’s 2nd and 3rd ... in a low-income area and has more than 60 2nd and 3rd graders with ...
(Date:2/12/2016)... ... 12, 2016 , ... Young Asset Protection, a full service ... the latest charity campaign in their community enrichment program. Art Expression utilizes after-school ... cause are currently being accepted at: http://artexpressioninc.org/ . , Art Expression is ...
(Date:2/12/2016)... TX (PRWEB) , ... February 12, 2016 , ... ... of southwest Houston and surrounding communities by continuing it’s commitment to act as ... Family Promise. The organization works closely with area homeless families to fulfill immediate ...
(Date:2/12/2016)... ... February 12, 2016 , ... Homeowners now have ... possibilities. CertainTeed, North America’s leading brand of building products, has improved upon its ... in the mobile version of the ColorView® Exterior Style and Color Selector. Created ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... Feb. 12, 2016  This month,s issue of the ... takes an in-depth look at various causes and ... prescription drug spending, which has generated significant public outrage ... Editor-in-Chief Laura E. Happe , PharmD, MPH. ... , PharmD, MPH. --> In 2014 prescription ...
(Date:2/12/2016)... Feb. 12, 2016 /PRNewswire/ - Demers Ambulances announces its first delivery ... Okaloosa County Emergency Medical Services (EMS) ... and one LT2 van. Quality Emergency Vehicles in ... for the sale.  This is the latest in Demers, ongoing ... Vice President at Demers. --> Benoit LaFortune , ...
(Date:2/12/2016)... Kalifornien, 12. Februar 2016  Sequent Medical, Inc. ... von Patienten für eine Studie zur Sicherheit und ... speziell für die Behandlung von rupturierten intrakraniellen Aneurysmen ... Leiter der Neuroradiologie an der Universitätsklinik Bicètre in ... der CLARYS-Studie hat den ersten Patienten aufgenommen. ...
Breaking Medicine Technology: