- Selection of Higher Potency Corticosteroid For Phase 2b Trial to Improve Efficacy and Faster Onset of Symptomatic Relief
- Target Population to include Patients with Grade 2 and 3 Hemorrhoids
- Revised Program Discussed with the FDA
CRANFORD, N.J., March 6, 2018 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("CITIUS") ("Company") (CTXR), a specialty pharmaceutical company, announced that the Company is selecting a higher potency corticosteroid in its steroid/anesthetic topical formulation program for the treatment of hemorrhoids. The original topical preparation, CITI-001, was a combination of hydrocortisone acetate and lidocaine hydrochloride. The new formulation, CITI-002, will combine lidocaine with the higher potency corticosteroid for symptomatic relief of the pain and discomfort of hemorrhoids. While not used in combination in currently marketed products, the proposed corticosteroid is included as an FDA-approved topical product to treat a variety of dermatological disorders.
The Company held a Type C meeting with the FDA to discuss the results of the Phase 2a study and to obtain the Agency's view on development plans to support the potential formulation change for the planned Phase 2b study. Citius also requested the Agency's feedback on the Phase 2b study design, including target patient population, inclusion/exclusion criteria, and efficacy endpoints. The pre-clinical and clinical development programs for CITI-002 are planned to be similar to those conducted for the development of CITI-001 to support the design for a planned Phase 3 clinical trial.
Myron Holubiak, CEO of Citius, said, "We made this decision to take advantage of the efficacy exhibited with higher potency steroids in reducing inflammation and in the faster onset of relief for hemorrhoid patients. In our planned Phase 2b trial, we will focus our attention on more severe hemorrhoidal disease, Grade 2 and 3, where a prescription strength may be more urgently needed. We will also be using the proprietary formulation we have developed since completing our CITI-001 clinical trial."
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. is very large with over 25 million units of topical products for hemorrhoids being sold annually in the U.S."
Currently, there are no approved prescription products, alone or in combination, for the treatment of hemorrhoids. Citius plans to use the FDA's 505(b)(2) pathway for new drug approvals.
CITI-002 is under investigation and not approved for commercial use.
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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Vice President, Corporate Development