CRANFORD, N.J., Aug. 23, 2016 /PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius”) (OTC BB: CTXR), a specialty pharmaceutical company dedicated to developing and commercializing adjunctive cancer care and critical care drug products, announced completion of market research with in-depth interviews on patient-reported signs and symptoms of hemorrhoids and treatment outcomes with its Hydro-Lido product.
Citius and the market research group conducted in-depth, in-person and telephonic interviews of patients who were diagnosed with grade II and grade III hemorrhoid disease. The interviews examined patients’ experience with multiple concomitant symptoms and varying severity. In its phase 2a study, Citius used both individual signs and symptoms and a composite of these individual symptoms to measure the efficacy of its Hydro-Lido product. The composite of the symptoms, or the Global Score of Disease Severity (GSDS), was scrutinized in the patient survey. This Patient Reported Outcome (PRO) information provides Citius with more specific guidelines for designing the endpoints in its planned phase 2b study.
Citius’ topical Hydro-Lido product is being developed to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids. Hemorrhoids are a common gastrointestinal disorder characterized by pain, swelling, itching, tenderness, and bleeding. Hemorrhoids affect nearly 5% of the U.S. population, with 10 million patients reporting symptoms and a third seeking treatment from doctors. Between 50% and 90% of the population will experience hemorrhoid disease in their lifetime. The potential prescription market in the U.S. could exceed $1 billion, and over 25 million units of topical products for hemorrhoids are currently sold annually in the U.S.
Both Hydrocortisone and Lidocaine have each been separately approved by the FDA for other indications, and are commercially available and marketed by other companies. Currently, there are no approved prescription products, alone or in combination, for the treatment of hemorrhoids. Citius plans to use FDA’s 505(b)(2) pathway for new drug approvals to develop its Hydro-Lido product.
Myron Holubiak, CEO of Citius, said, “This patient-reported outcome study confirms our use of the Global Score of Disease Severity (GSDS) as a reliable measure of the hemorrhoid symptoms that directly affect patient lives, and allows us to differentiate the drug effect in reducing these symptoms.”
About Citius Pharmaceuticals, Inc.
Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infectives, cancer care and unique prescription products using innovative, patented or proprietary formulations of previously approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs. By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com
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