Citius Pharmaceuticals reports ‘positive’ results from Phase 2B Halo-Lido study

Citius Pharmaceuticals announced results from the company’s Phase 2b clinical study of Halo-Lido, 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 FDA to begin planning the next steps in the regulatory and clinical development program for CITI-002.