2023-06-20 09:23:59 ET
Shares of Citius Pharmaceuticals ( NASDAQ: CTXR ) gained ~5% pre-market Tuesday after announcing Halo-Lido, a topical treatment comprising lidocaine and halobetasol for hemorrhoid relief, outperformed in a Phase 2b trial.
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), indicating the therapeutic effect of Halo-Lido on hemorrhoidal symptoms.
In comparison, 29% and 21% of patients in high-dose halobetasol alone and lidocaine alone groups reached MCT, respectively.
As a percentage, more patients on CITI-002 indicated meaningful and statistically significant improvement versus those on lidocaine alone.
Including a 7-day follow-up, the combination products outperformed individual therapies, though there were no statistically significant changes between 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 guidance on Halo-Lido development.
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Citius gains on positive mid-stage data for hemorrhoid therapy