August 24, 2016 6:57 AM 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: 52
Chief Medical Officer
Chief Commercial Officer
Age: 53
Compensation as of Fiscal Year 2016.

Tris Pharma, Inc. Key Developments

Tris Pharma Announces the Launch of DYANAVEL™ XR (amphetamine) Extended-Release Oral Suspension, CII for the Treatment of Children with ADHD

Tris Pharma, Inc. announced the launch of DYANAVEL™ XR (amphetamine), CII, the first and only extended-release liquid amphetamine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older. DYANAVEL XR is now available in U.S. pharmacies by prescription only. DYANAVEL XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others, and is against the law. Once-daily liquid DYANAVEL XR helps doctors customize the dose for each appropriate child with ADHD to balance symptom control and side effects. The starting dose is 2.5 or 5 mg, taken once daily in the morning with or without food. The low starting dose may be adjusted by 2.5 to 10 mg per day, every 4 to 7 days, up to a maximum dose of 20 mg per day. Doctors may be able to adjust the dose within the same prescription. Prior to prescribing a central nervous system (CNS) stimulant, including DYANAVEL XR, a healthcare provider should assess for the presence of heart disease. DYANAVEL XR received approval from the U.S. Food and Drug Administration (FDA) in October 2015. Based on limited experience with DYANAVEL XR, side effects appear to be similar to other once-daily ADHD medicines with the same active ingredient. The most common side effects reported in the Phase 3 controlled study were epistaxis (nosebleed) (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).

Tris Pharma, Inc. Appoints Sharon Clarke to the Position of Chief Commercial Officer to Lead Tris' Brand Business and Launch First Commercial Product

Tris Pharma, Inc. appointed Sharon Clarke to the position of Chief Commercial Officer to lead Tris' brand business and launch its first commercial product. Sharon was most recently Head of Commercial Operations of Virginia based Kaleo Inc.

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.

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