Company Overview of Tris Pharma, Inc.
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
Monmouth Junction, NJ 08852
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
Compensation as of Fiscal Year 2016.
Tris Pharma, Inc. Key Developments
Vernalis plc and Tris Pharma, Inc. Announce FDA Acceptance of CCP-08 NDA for Full Review
Dec 21 16
Vernalis plc and Tris Pharma, Inc. (Tris) are announced that the U.S. Food and Drug Administration (FDA) has accepted the CCP-08 New Drug Application (NDA) for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 4 August 2017. Under the exclusive licensing and collaboration agreement announced in February 2012, Tris is developing up to six unique extended-release equivalents to existing immediate-release prescription cough cold treatments for the US market. CCP-08 is the third product from this pipeline to be accepted for full NDA review. The first product, Tuzistra XR, was approved by the FDA in April 2015 and was launched by Vernalis in September 2015 by a dedicated sales force. The second product, CCP-07, was accepted for full review by FDA in September 2016 and has a PDUFA date of 20 April 2017.
Vernalis plc and Tris Pharma, Inc. Announces FDA Acceptance for CCP-07 New Drug Application for Full Review
Sep 6 16
Vernalis plc and Tris Pharma, Inc. announced that the U.S. Food and Drug Administration has accepted the CCP-07 New Drug Application for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act target date for conclusion of its review of 20 April 2017. Under the exclusive licensing and collaboration agreement announced in February 2012, Tris is developing up to six unique extended release equivalents to existing immediate release prescription cough cold treatments for the US market. CCP-07 is the second product from this pipeline to be accepted for full NDA review. The first product, TuzistraXR, was approved by the FDA in April 2015 and was launched by Vernalis in September 2015 by a dedicated sales force.
Tris Pharma Announces the Launch of DYANAVEL™ XR (amphetamine) Extended-Release Oral Suspension, CII for the Treatment of Children with ADHD
Apr 19 16
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%).
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