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Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids
CITI-002 provides a meaningful reduction in symptom severity when compared to individual components alone Dose for Phase 3 trial selected; Citius to schedule
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"CITI-002 provides a meaningful reduction in symptom severity when compared to individual components alone\nDose for Phase 3 trial selected; Citius to schedule end of Phase 2 meeting with the FDA\nTrial validates Patient Reported Outcome (PRO) instrument developed to support a pivotal Phase 3 study \nCRANFORD, N.J., June 20, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (NASDAQ: CTXR) today announced results from the Company's Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoid symptoms. This trial was designed to assess the efficacy of the combination product, select the appropriate dose and endpoints for a Phase 3 trial and to validate the PRO. The high dose formulation of CITI-002, a lidocaine and halobetasol propionate combination formulation, provided a meaningful reduction in symptom severity, as reported by patients, when compared to individual components alone. Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study. Citius intends to schedule an end of Phase 2 meeting with the U.S Food and Drug Administration (FDA) to begin planning the next steps in the regulatory and clinical development program for CITI-002.\nCITI-002 Phase 2b Trial Overview\nApproximately 300 adults with a clinical diagnosis of symptomatic hemorrhoids were enrolled in the Halo-Lido Phase 2b study (NCT05348200), a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial. The study assessed a high dose (CITI-002H) and low dose (CITI-002L) formulation of the combination drug products in comparison to the single active drug monads: high dose halobetasol, low dose halobetasol and lidocaine.\nRecently, there has been a shift from the use of traditional clinical analysis and outcomes to patients' perspectives and patients' experiences in assessing treatment efficacy. Following the 21st Century Cures Act, higher emphasis is placed on using Patient Reported Outcome (PRO) instruments in clinical trials. Currently, for hemorrhoidal disease, there are no validated clinical outcomes assessment (COA) tools available in the US. The FDA directed Citius to develop a \"fit for purpose\" PRO instrument to assess the efficacy of treatments in this disease. Symptom intensity and impact data ...