Navigation Links
Tris Announces NDA Acceptance of Extended Release Carbinoxamine Oral Suspension for the Treatment of Allergies in Kids Two Years and Older

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

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:
(Date:11/25/2015)... 2015  The American Academy of Pediatrics (AAP), ... the March of Dimes cheered today,s signature into ... Act of 2015 (S.799), which takes much-needed ... exposed to drugs, such as opioids, and to ... three organizations have worked together leading advocacy efforts ...
(Date:11/25/2015)... 2015 On Tuesday, November 24, 2015, ... against Wright Medical Technology, Inc. for product liability ... hip implant device, awarded $11 million in favor ... trial and three days of deliberations, the jury ... defectively designed and unreasonably dangerous, and that Wright ...
(Date:11/25/2015)... Israel , November 25, 2015 ... KTOV ) (TASE: KTOV), a biopharmaceutical company focused ... treatment of various clinical conditions, today announced the closing ... American Depository Shares ( ADSs ), each representing 20 ... up to 3,158,900 ADSs. The ADSs and warrants were ...
Breaking Medicine Technology:
(Date:11/28/2015)... Aliso Viejo, CA (PRWEB) , ... November 28, 2015 , ... ... 30 new fully customizable media panels to choose from, the possibilities are endless. Users ... angle, and more. With the ProPanel: Pulse masking effects, users are sure to get ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... According to ... out by the University of Toronto and the University of British Columbia suggested that ... for head injuries. The article explains that part of the reason for the controversial ...
(Date:11/27/2015)... ... 27, 2015 , ... A team of Swiss doctors has released a report ... has just posted the findings on the website. Click here to read the ... 136 mesothelioma patients who were treated with chemotherapy followed by EPP surgery. Among the ...
(Date:11/27/2015)... ... 2015 , ... Lizzie’s Lice Pickers just announced a special promotion that will ... their purchase of lice treatment product. In addition, customers will receive a complimentary head ... “Finding lice is a sure way to ruin the holidays, so we encourage all ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating community ... 30 (see Table 1-1 ). More than 3.7 billion people under the age ... type 1 (HSV-1), according to WHO's first global estimates of HSV-1 infection . , ...
Breaking Medicine News(10 mins):