Citius Pharmaceuticals Reports Results from Phase 2a Trial of Hydrocortisone and Lidocaine Combination Cream in Patients with Grade I and II Hemorrhoids

Citius Pharmaceuticals,  Inc. (OTCQB:CTXR) today announced top line data from the first Phase 2a clinical trial of hydrocortisone acetate (HC) and lidocaine hydrochloride (L) as single agents and in combination (HC+L)  in patients with grade I and II hemorrhoids.  Citius’ hydrocortisone and lidocaine cream is targeting to become the first FDA –approved prescription product to treat hemorrhoids in the U.S.
According to the press release:

In this randomized, double blind study of topical formulations of hydrocortisone, lidocaine and hydrocortisone + lidocaine were tested in patients with Grade I and II hemorrhoids.  There have been no historical randomized, placebo-controlled studies of these two drugs used either individually or in combination to treat hemorrhoids.  Therefore, this study’s objective was to obtain data to inform the design of future studies.  In this study, 210 patients were treated twice daily for 14-days with either placebo or one of the six active drug treatments (i.e., two concentrations of each HC, L and HC+L).  Patients kept a diary of their symptoms. Additionally, there were 4 physician assessments during which patients were evaluated on the Global Score of Disease Severity (GSDS) scale as well as on the individual signs and symptoms of hemorrhoids such as bleeding, pruritus and overall pain and discomfort, and time to the onset of symptom relief.

Mr. Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharmaceuticals, Inc. stated:

We are pleased with the results of this study which was intended to test the hypothesis that a steroid and anesthetic drug combination can be an effective way to reduce the symptoms of hemorrhoids. As expected, the data provides a positive directional signal and also indicate early reduction of symptoms. We look forward to submitting these results to the FDA as we move toward commercialization of our product within this $1 billion market with unmet need.

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