Hydrocortisone-Lidocaine Formulation

Prescription Strength Topical for Symptomatic Hemorrhoid Treatment

Overview

Citius is developing a proprietary topical formulation of hydrocortisone (3%) and lidocaine (5%) to provide anti-inflammatory and anesthetic relief to persons suffering from Grade I and II hemorrhoids. 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 hydrocortisone-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.

Summary of Opportunity
  • We believe Citius’ hydrocortisone and lidocaine formulation could become the first FDA-approved product to treat hemorrhoids in the United States.
  • By age 50, about half of adults have had to deal with the pain, bleeding, itching, and discomfort associated with hemorrhoids.
  • 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 ended June 2012, comprising an estimated $80 million annual market.

OTC hemorrhoid product sales are approximately 20 million units annually.

Medical Need

Hemorrhoids are a common gastrointestinal disorder, characterized by itching, pain, swelling, tenderness and bleeding. In the U.S., hemorrhoids affect nearly 5% of the population, with approximately 10 million persons annually reporting symptoms of hemorrhoidal disease. Of these patients, approximately one-third visit a physician for evaluation and treatment. Although hemorrhoids are not life-threatening, individual patients can suffer agonizing symptoms which can limit social activities and have a negative impact on quality of life. Learn more about hermorrhoids >>

If Citius receives FDA approval for its topical hydrocortisone-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, Citius may be the only product on the market proven to be safe and effective for the treatment of hemorrhoids.

Phase 2a Study*

In a randomized, double blind study, 210 patients with Grade I and II hemorrhoids were treated twice daily for 14-days. Patients received either a placebo or one of six active drug treatments, with two concentrations each of hydrocortisone, lidocaine, or a hydrocortisone-lidocaine combination. Patients kept a diary of their symptoms. Additionally, there were four physician assessments during which patients were evaluated on the Global Score of Disease Severity (GSDS) scale as well as on the individual signs and symptoms of hemorrhoids such as bleeding, pruritus, overall pain and discomfort, and time to the onset of symptom relief.

Level Improvement Global Severity

Within the first few days of treatment the highest concentration of the hydrocortisone-lidocaine combination was directionally superior to the placebo as measured by the number of subjects experiencing a minimum of two levels improvement from baseline according to the GSDS scale. This study was not powered to obtain statistical significance; however the data suggest that the combination product may also perform better than hydrocortisone or lidocaine alone.

Pruritus (Severe Itching)

The hydrocortisone-lidocaine combination seemed to achieve 88.9% greater relief at Day 2 as compared to any of its components alone.*

Pain and Discomfort

The hydrocortisone-lidocaine combination seemed to achieve 85.7% greater relief of pain and discomfort at Day 2 as compared to any of its components alone.*

* Study was not powered to show statistical significance; its purpose was to inform future study design.