Citius Pharmaceuticals Addresses Problem That Affects 10 Million People in the U.S.: Hemorrhoids

The Company's Hydrocortisone-Lidocaine Cream Completed Phase 2a and the Company Looks to Accelerate Commercialization Utilizing FDA's 505(b)(2) Pathway for New Drug Approvals

CRANFORD, N.J., July 25, 2016 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") (OTC BB: CTXR), a specialty pharmaceutical company dedicated to acquiring, developing and commercializing adjunctive cancer care and critical care drug products, announced significant progress in its development efforts of its Hydro-Lido cream to treat hemorrhoids. In February, the Company reported results from the Phase 2a trial of its Hydrocortisone and Lidocaine Combination Cream in patients with Grade I and II hemorrhoids, and the data suggest that the Hydro-Lido combination may show faster onset of relief of symptoms and reduction in disease severity as compared to its active components or the cream vehicle.

Citius' topical Hydro-Lido product is 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 hemorrhoidal disease in their lifetime. The estimated market in the U.S. is over $1.2 billion, and over 25 million units of topical products for hemorrhoids are 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. But, 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, "As expected, our Phase 2a trial provided insights into optimizing the formulation for our Hydro-Lido hemorrhoid cream.  The trial also helped us identify how and when these therapies help patients.  Additionally, our recently conducted market research has informed us as to the symptoms that matter most to patients. This data is helping us generate study endpoints that should be both meaningful to the patients and provide a basis for approval by the FDA.  This is a large market opportunity; Hydro-Lido would be the first FDA-approved prescription product to treat hemorrhoids in the U.S. We are extremely pleased with our progress."

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

Safe Harbor

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius.  You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. 

Contact:
Andrew Scott                                                                                   
Vice President, Corporate Development               
646-522-8410; ascott@citiuspharma.com

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SOURCE Citius Pharmaceuticals, Inc.