Halobetasol-Lidocaine Formulation
(CITI-002)
​Prescription Strength Topical for Symptomatic Hemorrhoid Treatment

Halo-Lido Overview

Citius Pharmaceuticals is developing a proprietary topical formulation of halobetasol and lidocaine using 505(b)(2) to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids.

Summary of Opportunity

  • There are no FDA-approved prescription products on the market for hemorrhoids.
  • Citius’ halobetasol and lidocaine formulation could become the first FDA-approved product to treat hemorrhoids in the United States.
  • According to IMS, over 25 million units of topical combination prescription products for hemorrhoids were sold in the United States during the twelve-month period ending June 2012, comprising an estimated $80 million annual market.

Although there are numerous prescription and over-the-counter (OTC) products commonly used to treat hemorrhoids, none currently possess safety and efficacy data generated from rigorously-conducted clinical trials. Citius believes its halobetasol-lidocaine product will become an important treatment option for physicians who want to provide their patients with a therapy that has demonstrated safety and efficacy in treating hemorrhoids, an uncomfortable and often recurring condition.