Citius Pharmaceuticals which is a specialty pharmaceutical company announced that the Company is finalizing 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. 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.
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.”
Currently, there are no approved prescription products either solitary or in combination for the treatment of hemorrhoids. Citius plans to use the FDA’s 505(b)(2) pathway for new drug approvals.