FDA Signs Off Citius Pharma's Phase 2 Trial With Halo-Lido In Hemorrhoids

The FDA has issued a Study May Proceed letter for Citius Pharmaceuticals Inc's CTXR Halo-Lido to treat hemorrhoids. The Company anticipates initiating a Phase 2b study in 1H of 2022.

  • Halo-Lido is a proprietary topical formulation of halobetasol and lidocaine intended to provide symptomatic relief to individuals suffering from hemorrhoids. 
  • Hemorrhoid is a gastrointestinal disorder characterized by pain, swelling, itching, tenderness, and bleeding. 
  • The Phase 2b study is designed as a multi-center, randomized, dose-ranging, double-blind, parallel-group comparison. 
  • Five cohorts of adults with a clinical diagnosis of symptomatic Goligher's classification Grade II or Grade III hemorrhoids will be dosed. 
  • Approximately 60 subjects per cohort are expected to be enrolled, for a total of 300 subjects. The primary endpoint of the study will be the reduction in hemorrhoidal symptoms. 
  • The secondary endpoint will reduce hemorrhoidal bother (such as bowel movement interference and pressure) following treatment.
  • Patients will utilize Citius's ePRO distributed to subjects using a smartphone app to record information and assessments.
  • Price Action: CTXR shares are trading 5.19% higher at $1.62 during the market session on the last check Tuesday.

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