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Citius Pharmaceuticals Announces FDA Acceptance of IND Application for its Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids
Study expected to begin enrolling patients in the first half of 2022 Hemorrhoids affect approximately 5% of the US population, with more than 10 million
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Study expected to begin enrolling patients in the first half of 2022\n Hemorrhoids affect approximately 5% of the US population, with more than 10 million patients annually reporting symptoms\n\n\nCRANFORD, N.J., Feb. 15, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has issued a Study May Proceed letter for Halo-Lido for the treatment of hemorrhoids. The Company is addressing recommendations made by the FDA and anticipates initiating a Phase 2b clinical study in the first half of 2022.\nHalo-Lido is a proprietary topical formulation of halobetasol and lidocaine that is intended to provide symptomatic relief to individuals suffering from hemorrhoids. Hemorrhoids are a gastrointestinal disorder characterized by pain, swelling, itching, tenderness, and bleeding. Although hemorrhoids are not life-threatening, individual patients often suffer painful symptoms that can limit social activities and have a negative impact on the quality of life. More than half of the U.S. population will experience hemorrhoidal disease at least once in their life. Each year, nearly 10 million patients in the U.S. report symptoms. \n\"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,\" stated Myron Holubiak, Chief Executive Officer of Citius. \"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 hemorrhoids,\" added Holubiak.\nAbout the Halo-Lido Phase 2b Study\nThe Phase 2b study is designed as a multi-center, randomized, dose-ranging, double-blind, parallel group comparison. Five cohorts of adults with a clinical diagnosis of symptomatic G...