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. Halo-Lido is a clinical phase product candidate. The results of the ongoing and any future clinical trials will determine whether we seek regulatory approval for Halo-Lido.
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 hemorrhoids are sold in the US
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.