Combination Therapy for Hemorrhoids: Citius' Combination Products Shows Meaningful Reduction In Symptoms

Citius Pharmaceuticals Inc's CTXR Halo-Lido, a topical treatment comprising lidocaine and halobetasol for hemorrhoid relief, significantly reduced symptom severity compared to individual components alone in Phase 2b trial.

Hemorrhoid is characterized by swollen and inflamed veins in the rectum and anus that cause discomfort and bleeding.

The randomized trial involving about 300 adults was designed to evaluate high and low doses of Halo-Lido (CITI-002) against lidocaine or halobetasol alone.

After seven days of therapy, 42% of the patients in the high-dose CITI-002 arm achieved a meaningful change threshold (MCT), compared to patients treated with high-dose halobetasol alone (29%) or patients treated with lidocaine alone (21%).

As a percentage, more patients on CITI-002 indicated meaningful and statistically significant improvement versus those on lidocaine alone.

The combination therapies provided faster relief compared to individual monads, and the relief persisted after completing treatment, although no statistical significance was determined in the changes between the comparison groups.

There were no safety concerns or serious adverse events during the 7-day treatment or follow-up periods.

The company intends to submit the findings to the FDA at an end-of-Phase 2 meeting it plans to seek from the regulator to obtain further.

Price Action: CTXR shares are up 3.66% at $1.28 on the last check Tuesday.