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November 26, 2015 8:42 PM ET


Company Overview of Tris Pharma, Inc.

Company Overview

Tris Pharma, Inc., a specialty pharmaceutical company, researches, develops, manufactures, and markets over-the-counter, Rx branded, and specialty generic products in the United States. The company develops extended release formulations for products intended for children, seniors, and adults who have difficulty swallowing pills and require multi-dose treatment. It also offers OralXR+, a particulate-based technology in which millions of small particles deliver the drug over time; Nobuse, an abuse resistant proprietary technology; and specialty generic products in immediate and extended release versions. In addition, it offers Lipisol for lipophilic/insoluble drugs (log P 1 to 5) as liquid-fil...

2033 Route 130

Brunswick Business Park

Suite D

Monmouth Junction, NJ 08852

United States

Founded in 2000





Key Executives for Tris Pharma, Inc.

Founder, Chief Executive Officer and President
Vice President of Operations & Technical Services
President of Generic Pharmaceuticals Business
Age: 51
Chief Medical Officer
Vice President of Human Resources
Compensation as of Fiscal Year 2015.

Tris Pharma, Inc. Key Developments

Tris Pharma, Inc. Receives FDA Approval of Dyanavel XR

Tris Pharma, Inc. announced that the U.S. Food and Drug Administration has approved Dyanavel XR (amphetamine), extended-release oral suspension, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years and older. With this approval, Dyanavel XR becomes the only once-daily, extended release amphetamine-based oral liquid approved for the treatment of ADHD in children. The approval is based on a Phase III randomized, placebo-controlled, laboratory classroom efficacy study conducted in 108 children (ages 6 to 12 years, who met DSM-IV criteria for ADHD). The study, which included a 5-week, open-label, dose optimization followed by a 1-week, double-blind treatment period, demonstrated a positive outcome by meeting its primary endpoint of change from pre-dose in the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)-Combined score at 4 hours post-dosing. Dyanavel XR also met key secondary endpoints by demonstrating an onset of clinical effect at one hour that persisted through 13 hours post dosing compared to placebo. The most common adverse reactions (>/= 2% in the Dyanavel XR group and greater than placebo) reported in the study were: epistaxis (nose bleed), allergic rhinitis and upper abdominal pain. Tris developed Dyanavel XR using its patented LiquiXR technology, a delivery system comprised of both immediate-release and extended-release amphetamine. By utilizing ion exchange polymeric chemistry, continuous release of amphetamine was achieved throughout the day.

Tris Pharma Launches Generic Tussionex

Tris Pharma announced the launch of Tris-labeled generic TUSSIONEX, an extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex. Tussionex, originally approved in the early 1980's, had no generic competition until 2010 when Tris Pharma's generic product entered the market under an exclusive distribution agreement with Par Pharmaceuticals. Under the terms of the distribution agreement, Par had the exclusive right to market Tris Pharma's hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension for a five year period ending September 30, 2015. With the conclusion of the five year term, the rights have reverted back to Tris and as of October 1, 2015, hydrocodone polistirex and chlorpheniramine polistirex ER Suspension in 115ml and 473 ml bottles (compare to Tussionex) will be marketed and distributed by Tris Pharma's generic business. Unlike the original product based on 1970's technology involving organic solvent based coating, Tris' product is based on its patented and highly versatile technology, LiquiXR, which avoids the use of toxic organic solvents by employing an aqueous based coating system. Tris has pioneered the delivery of taste-neutral, extended release dosage forms such as liquids, ODT/chewable tablets, and film strips that are otherwise traditionally associated with immediate release. Manufactured at Tris' U.S. Food and Drug Administration (FDA)-inspected, facility in Monmouth Junction, NJ, Hydrocodone Polistirex & Chlorpheniramine Polistirex 10mg/8mg ER Suspension in 115ml and 473 ml bottles (compare to Tussionex) are now available in the U.S. through wholesalers and distributors, as well as directly to the trade. Hydrocodone Polistirex & Chlorpheniramine Polistirex 10mg/8mg ER Suspension was approved by the FDA on October 1, 2010. It is distributed in accordance with FDA and U.S. Drug Enforcement Administration (DEA) regulations governing the handling of CII controlled substances. Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age or older. Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine. The use of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.

Vernalis plc and Tris Pharma Announce Availability of Cough Relief Syrup in US

Vernalis plc and Tris Pharma announced the availability of Tuzistra XR, an extended-release oral suspension, CIII, indicated for cough relief, in the US. Tuzistra XR, was approved by the FDA on April 30, 2015. It is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. Tuzistra XR is the only codeine-based extended-release cough cold syrup available to patients and physicians in the US. Tuzistra XR was developed using Tris Pharma's liquid sustained release technology, LiquiXR, which allows for extended drug delivery throughout a 12-hour dosing period.

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