Citius Pharmaceuticals Inc. (NASDAQ: CTXR) has announced that the US FDA has issued a Study May Proceed notice for Halo-Lido for hemorrhoids treatment. The company is responding to FDA suggestions and plans to start a Phase 2b clinical trial in the 1H of 2022.
Halo-Lido is a halobetasol and lidocaine mixture
Halo-Lido is a patented topical mixture of halobetasol with lidocaine that is used to treat hemorrhoids and offer symptomatic relief. Pain, swelling, itching, soreness, and bleeding are all symptoms of hemorrhoids, a gastrointestinal condition. While hemorrhoids really aren’t life-threatening, specific patients may experience unpleasant symptoms that impede social activities and lower quality of life. The hemorrhoidal illness affects over 50% of the US population at some point in their lives. Nearly ten million individuals in the United States report symptoms each year.
CEO Myron Holubiak stated, “This is an important next step in the clinical development of our Halo-Lido program. We have worked closely with the FDA to design our Phase 2b study protocol and look forward to beginning the study in the coming months. We appreciate the agency’s guidance in developing our proprietary electronic smartphone-enabled Patient Reported Outcome (ePRO) instrument, which we believe will encourage more immediate capture of important safety and efficacy data, and bring us closer to offering relief to millions of individuals suffering from the discomfort of haemorrhoids.”
Study to enrol 30 subjects with symptomatic Goligher’s categorization
Halo-lido study is a randomized, double-blind, dose-ranging, parallel-group comparison and multicentre study. Adults with bothersome Goligher’s categorization Grade II or Grade III hemorrhoids will receive the treatment in multiple cohorts. A sample of 30 individuals are scheduled to be recruited, with 60 participants per cohort. The study’s primary objective will be hemorrhoidal symptoms burning, pain, itching, and swelling) reduction after therapy. The improvement in hemorrhoidal discomfort (such as bowel movement hindrance and pressure) after therapy will be the secondary goal.
Patients will collect data and assessments using Citius’s innovative and proprietary ePRO, which will be supplied to subjects via a smartphone app.