Could a new prescription drug treat this common disease?

The Halo-Lido drug combination is set to be the first prescription treatment of its kind approved by the U.S. Food and Drug Administration for this widespread medical condition, a report by DawsonJames noted.

Citius Pharmaceuticals Inc (CTXR:NASDAQ) has seen the first patient enrolled in its Phase 2b clinical trial of Halo-Lido as a treatment for hemorrhoids, DawsonJames Securities analyst Jason Kolbert reported in an April 26 research note.

Dawson James notes Citius Buy.

Additionally, Citius offers investors significant return potential between its current share price of $1.11 and the target price per share of $10 assigned to it by DawsonJames.

As for the biopharma’s phase 2b study, in which several centers will participate, five cohorts of 60 adult patients each will be enrolled, for a total of 600, explained Kolbert. Participants will have a clinical diagnosis of symptomatic grade II or III hemorrhoids.

Citius’ Halo-Lido, noted Kolbert, is a combination of lidocaine and the corticosteroid halobetasol, both of which are used to treat the symptoms of hemorrhoids.

Kolbert pointed out that the demand for a drug like Halo-Lido is significant due to several factors. One is the current paucity of prescription hemorrhoid treatments approved by the United States Food and Drug Administration. Halo-Lido would be the first, if the federal agency gave it the green light.

Second, existing hemorrhoid therapies only provide temporary relief and lack efficacy data. These are mostly over-the-counter (OTC) remedies, such as Preparation H and stool softeners, but also include a few prescription products, such as pain relievers and topical steroids.

“Despite these shortcomings and the lack of reimbursement, there is significant patient and physician demand for these products,” Kolbert wrote. He added that people with hemorrhoids purchase 22 million over-the-counter products and 4 million prescription products for the condition each year.

Finally, hemorrhoids are prevalent in the United States with approximately 12 million people having them. This group is an existing market for effective prescription hemorrhoid treatment.

Kolbert also pointed out that patients with hemorrhoids typically need repeat treatments, up to three to five per year. This is due to a high recurrence rate as the available treatments are not curative.

“Therefore, we believe it is more appropriate to view the hemorrhoids market as a chronic therapy market rather than a single-use therapy market,” Kolbert wrote.

Dawson James notes Citius Buy.

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Disclosures for Dawson James Securities, Citius Pharmaceuticals, April 26, 2022

Dawson James Securities, Inc. (the “Company”) is a member of the Financial Industry Regulatory Authority (“FINRA”) and the Securities Investor Protection Corporation (“SIPC”).

The Firm does not make a market for the securities of the subject company(ies). The company has NOT entered into an investment banking relationship with the relevant company in the past twelve months, either as manager or co-manager of a public offering and has NOT received any compensation as a result of these relationships. The company may in the future request remuneration for investment banking services from the company or companies concerned. The Firm has not received any other remuneration from the company(ies) concerned during the last 12 months for services unrelated to the management or co-management of a public offering.

Neither the research analyst(s) whose name appears on this report nor any member of his/her/their household is an officer, director or member of the advisory board of these companies. The firm and/or its directors and employees may hold securities of the company or companies mentioned in this report and may increase or decrease the holdings in the future. As of April 7, 2022, the company as a whole did not own 1% or more of any class of common equity securities of the company(ies) subject of this report. The firm, its officers, directors, analysts or employees may transact and hold long or short positions in the securities (or options or warrants relating to such securities) of the company or companies subject to this report. The Company may transact as principal or agent in these securities.

Analysts do not receive any direct compensation in connection with the firm’s investment banking activities. All company employees, including the analyst(s) responsible for preparing this report, may be eligible to receive a non-product or service-specific monetary bonus that is based on various factors, including total the firm and its affiliates as well as a portion of the proceeds from a large pool of investment vehicles consisting of elements of compensation generated from investment banking activities, including but not limited to , shares and/or warrants, which may or may not include the securities referenced in this report.

Analyst Certification: The analyst(s) whose name appears in this research report certify that 1) all opinions expressed in this report accurately reflect their personal views on all securities or issuers involved; and 2) no part of the Research Analyst’s compensation has been, is or will be directly or indirectly related to the specific recommendations or opinions expressed by the Research Analyst in this Research Report; and 3) all Dawson James employees, including the analyst(s) responsible for the preparation of this research report, may be eligible to receive a monetary award not specific to a product or service. which is based on various factors, including the total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a large pool of investment vehicles comprised of components of compensation generated from banking activities. investment, including but not limited to stocks and/or warrants, which may or may not include the securities referenced in this report.

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