A phase 2/3 multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study looking at Nalbuphine ER for prurigo nodularis will evaluate safety and efficacy in 63 patients.
Trevi Therapeutics announced today that enrollment for a phase 2/3 study of Nalbulphine ER for prurigo nodularis is complete. The company expects to report data from that study in the third quarter of 2016.
There is no FDA approved medication for prurigo nodularis. Nalbuphine ER is an oral extended release opioid.
âBased on the âopioid hypothesisâ in itch, a drug with Âµ-opioid receptor antagonist or k-opioid receptor agonist properties would be expected to have anti-pruritic effects. Nalbuphine ER has both mechanisms of action,â according to TreviTherapeutics.com.
Nalbulphine ER has shown efficacy as a pruritus treatment in animal studies and human clinical trials, including in hemodialysis patients with uremic pruritus, according to a company press release.
The upcoming multi-center, randomized, double-blind, placebo-controlled, parallel, three-arm study will evaluate oral Nalbuphine ERâs safety of anti-pruritic efficacy in 63 prurigo nodularis patients. There will be a two-week titration period, followed by an eight-week blinded period on a fixed dose of the drug or placebo, as well as a wash-out period. Subjects will be eligible to roll-over into a one-year open label extension study, which will provide more data on the drug, including whether long-term itch reduction results in the healing of the skin lesions characteristic of prurigo nodularis.