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February 09, 2016 3:23 AM ET

Pharmaceuticals

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

Phone:

732-940-2800

Fax:

732-940-2855

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

U.S. Food and Drug Administration Approves Tris Pharma, Inc.'s First-Ever Extended-Release Chewable Tablet

Tris Pharma, Inc. announced that the U.S. Food and Drug Administration approved the first-ever extended-release chewable tablet, capping off a highly productive year with three Tris-developed NDAs approved in a calendar year. Prior to Tris' breakthrough ER chewable technology, extended-release tablets and capsules typically carried a warning, should not be chewed or crushed. With other controlled-release dosage forms, chewing or crushing can cause dose dumping which can greatly increase the concentration of a drug in the body and thereby produce adverse effects or even drug-induced toxicity. In clinical studies, Tris has demonstrated its extended-release chewable tablet technology releases drug consistently whether it is chewed or swallowed whole. This patent-protected technology offers patients convenience, flexibility and confidence. ER chewable tablets are an extension of Tris' LiquiXR® platform, a particulate based technology where hundreds of millions of tiny (about 100 microns) particles deliver drug over time. The extended release is facilitated by an extremely robust and flexible particle coating, which is why chewing does not compromise the release profile. The same particles can be used to formulate various oral extended-release dosage forms such as liquid suspensions, dispersible tablets, film strips, and ODT's. Further, Tris' ER chewable technology can be scored just like any immediate-release tablet. Tris has a solid track record of breaking new ground within the drug delivery technology space including the first ever 24-hour extended-release oral liquid and now the first ever extended-release chewable tablet. The 2015 calendar year has been a highly productive year with three NDA approvals, all on their PDUFA dates, bringing a total of seven NDA approvals in the past six years. This would be an incredible accomplishment for any large company but is unheard of for a company of only 400 employees. This speaks well of combined R&D and Technical Service, Regulatory, and Medical teams. They have been outstanding all year in delivering great results.

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.

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