Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) announced enrolment of first patient in the Phase 2b clinical study of Halo-Lido for the treatment of hemorrhoids.
The Phase 2b clinical study is a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial.
Citius Pharma is planning to dose five cohorts of adults with a clinical diagnosis of symptomatic Goligher's classification Grade II or Grade III hemorrhoids, approximately 60 patients per cohort, out of total 300 patients.
The regulatory agency has provided guidance to Citius in developing a Patient Reported Outcome (ePRO) instrument, which enables patients to record and report important safety and efficacy data in real time.
Leonard Mazur, Executive Chairman, stated, “Currently, there are no FDA-approved prescription-strength treatments available to the millions of adults who suffer from hemorrhoid discomfort each year. If approved, Halo-Lido would be the first prescription product indicated for the treatment of hemorrhoids”.
Data read-out from this trial is anticipated in the second half of 2023.
Citius Pharmaceuticals is currently trading down at $1.10.
