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FDA guides reformulation, phase 2b study of topical hemorrhoid treatment
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After meeting with the FDA, Citius Pharmaceuticals announced it will reformulate its investigational topical hemorrhoid treatment with a stronger corticosteroid to boost the efficacy and speed of symptom relief.
The new formulation — known as CITI-002 — will combine the stronger corticosteroid with lidocaine, and the company plans to test it in a phase 2b trial. Citius previously tested a formulation — CITI-001 — that included lidocaine and hydrocortisone, according to a press release.
“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,” Myron Holubiak, CEO of Citius said in the press release.
Citius met with the FDA to review the results of its phase 2a study of CITI-001, and to discuss the agency’s view on development plans to support the formulation change for the upcoming phase 2b study. The company said development programs for CITI-002 will be like those used for CITI-001 to support the design of a planned phase 3 study.
There are currently no prescription products approved for the treatment of hemorrhoids, a disorder that affects approximately 10 million people in the United States, according to the press release.
“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,” Holubiak said in the press release. “We will also be using the proprietary formulation we have developed since completing our CITI-001 clinical trial.”
Disclosure: Holubiak is employed by Citius.