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• Novel mechanism of action, highly differentiated safety profile, 2000+ subjects studied in 27 clinical trials across Europe and US; FDA Fast Track status granted
• NCE has potential to addresses significantly under-served market comprising acute and chronic pain, central and peripheral neuropathy, cancer pain, and addiction treatment

MONMOUTH JUNCTION, NJ, April 29, 2021 / PRNewswire/ – Tris Pharma, Inc. (“Tris”), a specialty pharmaceutical company with a robust portfolio of approved products and a late-stage pipeline of innovative product candidates for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and related conditions, today announced that it has acquired Park Therapeutics, a company developing a unique, first-in-class, investigational NCE for the treatment of pain which is Phase III-ready.  

Studies have demonstrated the potential for the NCE to provide strong efficacy in nociceptive and neuropathic pain, while maintaining a highly differentiated safety profile results from its unique, first-in-class dual mechanism of action as a highly potent agonist of the nociceptin/orphanin FQ (NOP), DOP and MOP receptors and partial agonist of KOP receptors.  The drug has been studied extensively in both Europe and the US in approximately 2,000 subjects in 27 clinical trials including 8 efficacy trials against both placebo and active comparators, such as Oxycontin, Nucynta, morphine and pregabalin. The NCE cebranopadol has been granted Fast Track status by the FDA and was initially developed by Grünenthal, a German company which specializes in pain. With the acquisition, Tris owns worldwide rights and all accompanying intellectual property for cebranopadol.

James Hackworth, Ph.D., co-founder and President of Park Therapeutics commented, “We have evaluated numerous NCEs, emerging technologies and different pathways in the pain space and we have never before seen such a potentially game-changing therapy. Cebranopadol’s potential to deliver a superior safety profile and strong efficacy provide for an effective tool to address acute and chronic pain without the risks associated with traditional opioids”.

Ketan Mehta, Founder and CEO of Tris Pharma added, “I have been pleasantly surprised to see the depth and breadth of data underscoring the superiority of treatment that this drug promises. We are fortunate to have this opportunity to acquire a late-stage asset and look forward to working with the FDA on its approval journey”. He continued, “We are equally fortunate to have James join Tris’ Leadership team as President of our Brand Division.  In this capacity, James will lead our Commercial team, Corporate Development and Medical Team effective May 3, 2021”.

About Tris Pharma

Tris Pharma is a New Jersey-based specialty pharmaceutical company focused on the development and commercialization of innovative medicines that address unmet patient needs. Tris has used its LiquiXR® technology platform to develop a portfolio of differentiated solid and liquid medications as well as a robust pipeline which spans multiple therapeutic categories, and its technology has formed the basis for numerous mutually value-adding development partnerships. Within the United States, Tris promotes its portfolio of ADHD products (described at www.TrisADHD.com) using its pediatric and CNS-focused sales force. For more information, please visit trispharma.com.