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 Atla
'/>"/>

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

Page: 1 2

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:9/30/2014)... is no stranger to the children of Tanzania. What ... to clinical services, including reliable diagnosis and evidence-based treatments. ... for use in Swahili, a major language of the ... Brown University and the University of Georgia (UGA) describe ... two sites in the country and found to be ...
(Date:9/30/2014)... NJ (PRWEB) September 30, 2014 ... and wellness, is opening another new medical specialty practice ... IMA Cardiology will be located within the ... Ziad Abbud and Dr. Isaac Tawfik of American Heart ... N.J. The new practice will offer Integrated Medicine Alliance ...
(Date:9/30/2014)... Las Vegas, NV (PRWEB) September 30, 2014 ... released by Blue Star Nutraceuticals designed to help maximize ... ingredients that optimizes the body’s absorption of glucose has ... review. , “The main purpose behind Glycodrive is ... that builds lean muscle,” reports Michaels. “Carbs are essential ...
(Date:9/30/2014)... VisitandCare.com reports that revenue for ... more than 79 percent in 2014, marking five straight ... total revenue tripled for its entirety of partnered medical ... has allowed them to partner with plastic surgery ... and privacy — with state-of-the-art surgical atmospheres aimed to ...
(Date:9/30/2014)... A group of Americans is headed to ... that, left unchecked, could create a catastrophic, global pandemic. No, ... Africa. John Rogers, the Executive Director the Eugene Bell Foundation ... a disease most think mankind conquered long ago: tuberculosis. , ... is on the comeback in several countries - what’s especially ...
Breaking Medicine News(10 mins):Health News:New diagnostic approach for autism in Tanzania 2Health News:New diagnostic approach for autism in Tanzania 3Health News:New diagnostic approach for autism in Tanzania 4Health News:Integrated Medicine Alliance Announces New Cardiology Practice 2Health News:Glycodrive Review Exposes Blue Star Nutraceutical’s Supplement for Leaner, Stronger Muscles 2Health News:VisitandCare.com Announces Record Demand for Plastic Surgery in Turkey 2Health News:VisitandCare.com Announces Record Demand for Plastic Surgery in Turkey 3Health News:VisitandCare.com Announces Record Demand for Plastic Surgery in Turkey 4Health News:US Delegation Heads to North Korea to Combat Tuberculosis Epidemic 2
... most common vascular complication after living donor liver ... devastating consequences. Surgical techniques are suggested to an ... surgical techniques, arterial reconstruction in LDLT has a ... techniques, the reconstruction of HA was accomplished in ...
... Thursday 17 June 2010: Smoking cigarettes is a significant ... have a negative impact on the effectiveness of anti-tumour ... treatments, according to results of two studies presented today ... League Against Rheumatism in Rome, Italy. A further study ...
... in shape may bolster the metabolic profiles of college ... fat percentages. In an epidemiological study, researchers at the ... University found an association between physical fitness, body fat ... to cardiovascular disease and Type 2 diabetes. ...
... ... , ... 17, 2010 -- SleepBetter.org, the web,s premier source for news, tips, and information on how ... to help their children settle down for a good night,s sleep. The Bedtime Stories ...
... Enhance your ... , ... 17, 2010 -- Whether it’s a backyard barbecue, family reunion, birthday party, picnic, July 4 ... sold at Walmart in the candy aisle, adds a new and exciting touch to your ...
... costlier drugs increased after new rules took effect, study ... in Medicare payments to doctors who administer outpatient chemotherapy ... among Medicare recipients, finds a new study. , "This ... would expect, but economists often encounter this sort of ...
Cached Medicine News:Health News:Smoking cigarettes is a predictor of RA and may negatively impact on efficacy of anti-TNFs 2Health News:Smoking cigarettes is a predictor of RA and may negatively impact on efficacy of anti-TNFs 3Health News:Physical fitness may help reduce chronic disease risk in college students 2Health News:Sleep Tips Web Site SleepBetter.org Expands The Bedtime Stories Project 2Health News:Sleep Tips Web Site SleepBetter.org Expands The Bedtime Stories Project 3Health News:Top Off Your Favorite Summer Treat with NOT JUST CEREAL™ 2Health News:Top Off Your Favorite Summer Treat with NOT JUST CEREAL™ 3Health News:Medicare Cuts May Have Led Docs to Prescribe More Chemo 2
(Date:9/30/2014)... MOUNTAIN VIEW, Calif. , Sept. 30, 2014 /PRNewswire/ ... today, which integrates with HealthKit in iOS 8 and ... with their doctors. The app harnesses native iOS technologies ... patients to maintain a robust connection with their doctors ... wearable health devices and the data they collect is ...
(Date:9/30/2014)... NEW YORK , Sept. 30, 2014 ... growth stage. Both established medical-device providers as well as ... Eastern European region, while simultaneously looking at ways to ... this sector. Using distributors is one of the effective ... the medical devices distribution market in Eastern European and ...
(Date:9/30/2014)... The report based on "Nutraceutical ... Growth and Forecast, 2007 - 2017," elaborated by Transparency ... billion in 2012 and is further expected to reach ... of 7.3% from 2012 to 2017. Nutraceutical ... especially to prevent chronic diseases that may occur to ...
Breaking Medicine Technology:HealthLoop Integrates with Apple's HealthKit Enabling Patients to Share Health Data with Their Doctors Right from their iPhone 2Medical Technologies Distributor Profiles in Eastern Europe 2Medical Technologies Distributor Profiles in Eastern Europe 3Nutraceutical Ingredient Market Will Reach USD 33.6 Billion Globally in 2018: Transparency Market Research 2Nutraceutical Ingredient Market Will Reach USD 33.6 Billion Globally in 2018: Transparency Market Research 3Nutraceutical Ingredient Market Will Reach USD 33.6 Billion Globally in 2018: Transparency Market Research 4
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: