Prescription strength topical for symptomatic hemorrhoid treatment

Halo-Lido (CITI-002) is a proprietary topical formulation of halobetasol and lidocaine that is intended to provide anti-inflammatory and anesthetic relief to individuals suffering from hemorrhoids. In the United States, hemorrhoids affect nearly 5% of the population, with approximately 10 million patients annually reporting symptoms.

Program Highlights

  • There are no FDA-approved prescription products on the market for hemorrhoids
  • Citius’ halobetasol and lidocaine formulation could become the first FDA-approved prescription product to treat hemorrhoids in the United States
  • According to IMS, over 25 million units of topical combination prescription products for are sold in the US
Hemorrhoids illustration

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 proprietary formulation 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.

If Citius receives FDA approval for its topical halobetasol-lidocaine combination formulation for the treatment of hemorrhoids, it may qualify for three years of market exclusivity for its dosage strength and formulation. In that case, Halo-Lido may be the only product on the market proven to be safe and effective for the treatment of hemorrhoids.