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• Non-opioid, novel mechanism of action for pain, highly differentiated safety profile
• Potential to address significant unmet needs in acute and chronic pain

MONMOUTH JUNCTION, NJ, December 7, 2022 / PRNewswire/ – Tris Pharma, Inc. (“Tris”), a fully integrated, innovation-driven CNS company with a robust portfolio of FDA-approved products for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), and a pipeline of treatments for pain, addiction, spasticity and narcolepsy, today announced that it has acquired rights to TRN-261 a non-opioid drug candidate that Tris intends to develop for multiple indications within acute and chronic pain.  

TRN-261 has been extensively studied, and a large amount of safety data exists supporting its further development.  The drug was subject to a full development program supporting the filing of a New Drug Application with the US Food and Drug Administration (FDA) for a use within a non-pain indication.   Subsequently, unrelated to safety, the FDA issued a Complete Response Letter to the Sponsor.  Separately, several studies of TRN-261 established proof of concept within both acute and chronic pain conditions for which only opioid based treatment options exist today.   

Tris intends to leverage TRN-261’s established safety profile and continue further development of TRN-261 within target pain indications.  The rights acquired by Tris to TRN-261 provide all commercial and regulatory rights to the drug and its associated intellectual property, including patents providing protection of the product until 2037.

James Hackworth, Ph.D., President, Brand Division at Tris commented, “There is a huge need for safer and non-addictive pain therapies worldwide.  We have evaluated numerous drug candidates and pathways for pain and are impressed by the data supporting the development of TRN-261.  TRN-261 shows potential to deliver strong efficacy and safety, while providing patients an alternative to traditional opioids”.

Ketan Mehta, Founder and CEO of Tris Pharma said, “With the addition of this new late-stage asset (TRN-261) and together with Cebranopadol (TRN-228), we have built a comprehensive pain pipeline that is both in advanced stages and unique in the industry.” Mr. Mehta further added, “I have been pleasantly surprised to see the depth and breadth of data underscoring these potential treatments for pain, which remain a huge unmet need.  We are fortunate to have this opportunity to acquire a late-stage asset and look forward to working with the FDA for its approval”.

About Tris Pharma

Tris is a fully integrated, innovation-driven CNS company that provides a differentiated approach to target unmet medical needs, including the application of novel technologies designed to enhance patient benefits across therapeutic categories. Founded in 2000, Tris’s CNS portfolio includes treatments for pain; addiction; spasticity in multiple sclerosis, cerebral palsy; narcolepsy; and ADHD. For more information, please visit  www.trispharma.com and www.trismedical.com.