Navigation Links
Tris Announces NDA Acceptance of Extended Release Carbinoxamine Oral Suspension for the Treatment of Allergies in Kids Two Years and Older
Date:3/9/2011

MONMOUTH JUNCTION, N.J., March 9, 2011 /PRNewswire/ -- Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced today that the US Food and Drug Administration (FDA) has accepted its Extended Release Carbinoxamine Oral Suspension NDA for the treatment of allergies in kids two years and older.  If approved, Tris Pharma's Extended Release Suspension will provide an alternative to the currently available immediate release formulations.

Carbinoxamine is a mildly sedating antihistamine with years of proven safety and efficacy.  Prior to 2006 carbinoxamine was widely used, with more than 100 marketed Carbinoxamine containing products including extended release solid dose and combination products.  However, nearly all of these were older products which hadn't gone through the FDA's rigorous approval process.  Following the 2006 DESI review, the FDA removed all carbinoxamine based products with the exception of two immediate release formulations which had been reviewed, creating a void for patients and doctors who valued the benefits associated with an extended release formulation.

A leading New York based pediatrician, Dr. Laura Garabedian, who often prescribes Carbinoxamine said, "I've always found Carbinoxamine extremely effective in treating allergy symptoms in children but don't typically prescribe it as first line therapy because the existing immediate release formulations need to be dosed multiple times per day including a dose while the child is in school thus making compliance poor.   I am looking forward to a true 12 hour formulation that tastes good.   The new product profile should translate to improved compliance and better outcomes."

Ketan Mehta, Tris President and CEO added, "This is the fourth NDA submission based on Tris' OralXR+ technology platform including Nexiclon™ XR,  a recently launched first ever 24-hour liquid Extended Release Suspension. Tris' pipeline includes several additional products targeted for the respiratory market, i.e. cough, cold, allergy therapies and are slated for submission over the next two years. Tris plans to launch Carbinoxamine Extended Release Suspension in 2012 season and is currently evaluating its options including partnering with other specialty Pharma companies. "

About OralXR+

OralXR+ is Tris' proprietary technology platform for providing sustained release dosage forms that do not require patients to swallow a traditional "pill" such as long acting versions of: liquid oral suspensions, chewable tablets, film strips, and ODT's.  The technology is based on patent-pending, highly robust and flexible tiny particulate coating where millions of small (about 100 microns) particles deliver drug over time.  The sustained release coating completely masks the unpleasant tasting drug particles facilitating great tasting dosage formulations.

About Tris Pharma

Tris Pharma is a specialty pharmaceutical company focused on the research and development of drug delivery technologies based products. Through its OralXR+ platform, Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris' Nobuse platform provides abuse-deterrence for opioids and other abuse-prone drugs. Tris' R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, USA. For more information, please visit www.trispharma.com.


'/>"/>
SOURCE Tris Pharma
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. ViroPharma Announces Securities Repurchase Program
2. Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2010 Financial Results
3. Warner Chilcott Announces Secondary Equity Offering
4. K-V Pharmaceutical Company Announces Comprehensive Patient Assistance Program for Makena™
5. PDL BioPharma Announces Conversion Rate Adjustments for 2.00% Convertible Senior Notes Due February 15, 2012 and 2.875% Convertible Senior Notes Due February 15, 2015
6. Vermillion Announces Presentation of Positive Ovarian Biomarker Data for Next Generation Test
7. Genus Oncology, LLC Announces Orphan Drug Status for GO-203-2c for Treatment of Pancreatic Cancer
8. Amicus Therapeutics Announces FDA Agreement to Commence Phase 2 Study of AT2220 Co-administered with Enzyme Replacement Therapy for Pompe Disease
9. Hill-Rom Announces Second Quarter 2011 Dividend
10. Idenix Announces Data Presentations at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL)
11. Jazz Pharmaceuticals Announces Fourth Quarter and Full Year 2010 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... , Oct. 11, 2017  True Health, a ... amplified its effort during National Breast Cancer Awareness ... cancer risks. ... Oncology calculated that more than 10 million American ... mutations in BRCA1 or BRCA2 and have not had ...
(Date:10/10/2017)... received FDA 510(k) clearance in May 2017 for its highly anticipated ... for endoscopy environments. An innovative secondary monitor solution, ZeroWire Mobile ... the improvement of patient outcomes, procedural efficiency, and the lowering of ... ... By ...
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... 2017 , ... The company has developed a suite of ... authorities worldwide. From Children’s to Adults 50+, every formula has been developed by ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, Preservative ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally ... care, have expanded their existing home health joint venture through an agreement, effective ... operating a joint venture home health company with Asante, delivering clinically integrated care, ...
(Date:10/12/2017)... ... 12, 2017 , ... HMP , a leader in healthcare events and ... Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie ... annual award competition recognizes editorial and design excellence across a range of sectors. This ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned ... Michigan’s 2017 Best and Brightest in Wellness® by Best and Brightest. OnSite Wellness ... on Friday, Oct. 20 from 7:30 a.m. to 2 p.m. at the Henry ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... in wound care advancements to physician colleagues, skilled nursing facility medical directors and ... the Treacherous Waters of Wound Care." , "At many of these conferences we ...
Breaking Medicine News(10 mins):