Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids
CRANFORD, 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.
- Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study.
- Approximately 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.
- Moreover, the current results reinforce our confidence in the safety and tolerability of CITI-002 and strongly support further evaluation of CITI-002 in a Phase 3 study.
- We are looking forward to sharing the Phase 2b data with the FDA and seeking guidance for further development of this drug."