Trevi Therapeutics, Inc. (Trevi), a drug development company focused on developing Nalbuphine ER for chronic pruritus, has commenced phase I, open-label study to characterize and compare the pharmacokinetics, safety and tolerability of escalating oral doses of nalbuphine hydrochloride extended release tablets in end-stage renal disease patients on hemodialysis as compared to healthy control subjects. The study will include 20 subjects and top-line data is expected by year-end.
Nalbuphine ER is an oral extended release formulation of nalbuphine hydrochloride which has previously only been approved as an injectable. Nalbuphine has a unique opioid receptor dual agonist/antagonist mechanism of action and has been shown in both animal and human clinical studies as being effective in pruritus. Because of the drug’s centrally acting dual mechanism of action, the Company believes Nalbuphine ER may have broad utility in treating chronic pruritus.
Jennifer Good, Trevi’s co-founder and president and CEO, said, “We have strong momentum inside Trevi as we initiate this important trial to establish the safety of Nalbuphine ER in the intended patient population of renally impaired patients and prepare to initiate an efficacy study in uremic pruritus in early 2014. We are also actively pursing a second indication in dermatology and anticipate initiating that efficacy trial next year as well.”
Trevi Therapeutics, Inc. is a drug development company focused on developing Nalbuphine ER for chronic pruritus (itch).