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:8/22/2017)... ... ... past six years, Lightning Labels has sent out a call for users of its custom ... creativity of their designs. Submissions this year were open from May 18 to July 1 ... winners of the sixth annual Photo Contest, along with the prizes they've received:, ...
(Date:8/22/2017)... ... August 22, 2017 , ... “Wilderness Voices”: a collection ... travel. “Wilderness Voices” is the creation of published author, Martha McKown, an ordained ... was inspired as a very young child when her older sisters studied High School ...
(Date:8/22/2017)... ... , ... TopConsumerReviews.com recently gave a best-in-class 5-star rating to Energy NADH, a ... of modern life continually makes more demands on time and energy, people are finding ... people in vicious high/low cycles and can also cause long term health issues. More ...
(Date:8/21/2017)... ... August 22, 2017 , ... ... I. Stevens as a 2017-2018 inductee into its VIP Woman of the ... NAPW is the nation’s leading networking organization exclusively for professional women, boasting more ...
(Date:8/21/2017)... ... 2017 , ... Marathon running has surged in popularity in ... running increases exposure to ultraviolet radiation, a carcinogen that promotes skin cancer. Studies ... half may be adequately protecting themselves with proper clothing and sunscreen. , ...
Breaking Medicine News(10 mins):
(Date:7/27/2017)... Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results ... reported second quarter net sales of $1.954 billion, an ... an increase of 2.1% on a constant currency basis.  ... LDR Holding Corporation acquisition, second quarter 2017 revenues decreased ... on a constant currency basis. ...
(Date:7/26/2017)... Colo. , July 26, 2017 E.I. ... Guttridge and the Bimini SharkLab to custom design the worlds ... images of sharks in their native habitat. In preparation ... Discovery Channel,s Shark Week, Dr. Guttridge approached EIMI ... take pregnancy diagnosis directly to hammerhead sharks underwater. ...
(Date:7/26/2017)... Sancilio Pharmaceuticals Company, Inc. (SPCI) today announced ... Altemia TM , an oral therapy for pediatric patients ... (SCD). The SCOT Trial, is a double-blind, placebo-controlled, dose-finding, ... Altemia TM in pediatric patients aged 5-17 years ... "The completion of ...
Breaking Medicine Technology: