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Trevi Therapeutics Announces the Issuance of Two Patents Covering the Oral Sustained Release Formulation of Nalbuphine ER

August 14, 2014

Patent estate includes Method of Use and Formulation Patents

NEW HAVEN, Conn.--(BUSINESS WIRE)-- Trevi Therapeutics, Inc. (“Trevi”), a clinical stage biotechnology company developing Nalbuphine ER for chronic pruritus conditions, today announced that it has received two issued U.S. patents with claims protecting the oral sustained release formulation of nalbuphine. The patent numbers are 8,771,732 and 8,765,175.

The Company believes that both of these patents will be Orange Book-listable. These two patents complement two additional issued formulation patents, as well as an issued patent protecting the method of use of Nalbuphine ER in the “Methods for Treatment of Pruritus,” which expires in December 2032. Trevi continues to prosecute additional claims to further enhance its existing patent estate protecting Nalbuphine ER in itch.

Jennifer Good, Trevi’s President and Chief Executive Officer, said, “We are pleased with the issued patent estate to date and will continue to pursue opportunities to protect Nalbuphine ER. Nalbuphine’s novel mechanism of action aligns well with multiple itch conditions, and we have initiated a pivotal trial in uremic pruritus and will be initiating a pivotal trial in prurigo nodularis later this year.”

About Trevi Therapeutics, Inc.

Trevi Therapeutics, Inc. is a clinical stage biotechnology company focused on developing Nalbuphine ER for chronic pruritus (itch). Pruritus develops in various dermatologic, metabolic, hematologic and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality. Prurigo nodularis is a chronic dermatologic condition characterized by severely pruritic nodules on the skin that are independent of underlying etiology. There are no approved therapies in the US or EU for either condition.

Nalbuphine ER is an oral extended release opioid with a unique opioid receptor dual agonist/antagonist mechanism of action, which has shown efficacy in addressing pruritus in both animal studies and human clinical trials. Because of Nalbuphine ER’s dual mechanism of action, the company believes it can have broad utility in treating chronic pruritus. Founded in 2011, Trevi is headquartered in New Haven, CT.

For additional information, visit www.trevitherapeutics.com.




Media:

Trevi Therapeutics, Inc.

Laura Brophy, 203-331-7618

mediarelations@trevitherapeutics.com

Source: Trevi Therapeutics, Inc.


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