Ulobetasol

Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids

Retrieved on: 
Tuesday, June 20, 2023
CMH, Pros, Ulobetasol, Patient-reported outcome, Quality of Life Index for Atopic Dermatitis, Lidocaine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PRO, Hemorrhoid, Clinical trial, 21st Century Cures Act, Patient, Trial of the century, Pain, Patent, Semantics, MCT, FDA, Safety, COA, Disease, Pharmaceutical industry, Medical device, Citius, Altius, Fortius

CRANFORD, N.J., June 20, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR) today announced results from the Company's Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoid symptoms.  This trial was designed to assess the efficacy of the combination product, select the appropriate dose and endpoints for a Phase 3 trial and to validate the PRO.  The high dose formulation of CITI-002, a lidocaine and halobetasol propionate combination formulation, provided a meaningful reduction in symptom severity, as reported by patients, when compared to individual components alone. Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study.  Citius intends to schedule an end of Phase 2 meeting with the U.S Food and Drug Administration (FDA) to begin planning the next steps in the regulatory and clinical development program for CITI-002.

Key Points: 
  • Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study.
  • Approximately 300 adults with a clinical diagnosis of symptomatic hemorrhoids were enrolled in the Halo-Lido Phase 2b study ( NCT05348200 ), a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial.
  • Moreover, the current results reinforce our confidence in the safety and tolerability of CITI-002 and strongly support further evaluation of CITI-002 in a Phase 3 study.
  • We are looking forward to sharing the Phase 2b data with the FDA and seeking guidance for further development of this drug."

Citius Pharmaceuticals Enrolls First Patient in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids

Retrieved on: 
Tuesday, April 26, 2022
COVID-19, Tenderness, Patent, Ulobetasol, Potency (pharmacology), Patient, EPRO, Pain, Clinical trial, T-cell lymphoma, Population, Pivotal, Goligher, Regulation of tobacco by the U.S. Food and Drug Administration, Research, U.S. Securities and Exchange Commission, Peripheral T-cell lymphoma, Degenerative disease, Life, Immunotherapy, Bleeding, Food, Regulation, Annual report, Drug Quality and Security Act, Securities Exchange Act of 1934, Hemorrhoid, Trial of the century, Lidocaine, Company, Itch, SEC, CGMP, Forward-looking statement, PTCL, Safety, IL-2R, Fast Track, Multimedia, FDA, Quality of life, Securities Act of 1933, CTCL, Swelling, Pharmaceutical industry, Citius, Altius, Fortius

CRANFORD, N.J., April 26, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the first patient has been enrolled in the Company's Phase 2b clinical study of Halo-Lido for the treatment of hemorrhoids.  If approved, Halo-Lido would be the first FDA-approved prescription product indicated for the treatment of hemorrhoids.

Key Points: 
  • If approved, Halo-Lido would be the first FDA-approved prescription product indicated for the treatment of hemorrhoids.
  • The Phase 2b study is a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial.
  • Five cohorts of adults with a clinical diagnosis of symptomatic Goligher's classification Grade II or Grade III hemorrhoids will be dosed.
  • The study will evaluate reduction in hemorrhoidal symptoms (including: pain, burning, itching, and swelling) following treatment and is expected to provide the foundation for development of the Phase 3 study.

Citius Pharmaceuticals Announces FDA Acceptance of IND Application for its Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids

Retrieved on: 
Tuesday, February 15, 2022
Potency (pharmacology), Itch, Patient, EPRO, CTCL, Food, Hemorrhoid, Quality of life, Company, Goligher, SEC, Immunotherapy, T-cell lymphoma, Smartphone, Regulation, Degenerative disease, Pressure, Drug Quality and Security Act, Lidocaine, Annual report, Safety, Securities Exchange Act of 1934, IL-2R, Regulation of tobacco by the U.S. Food and Drug Administration, Forward-looking statement, Pain, Pivotal, Securities Act of 1933, U.S. Securities and Exchange Commission, PTCL, CGMP, FDA, Bleeding, Population, Tenderness, Ulobetasol, Patent, Peripheral T-cell lymphoma, Research, Multimedia, COVID-19, Fast Track, Life, Swelling, Pharmaceutical industry, Citius, Altius, Fortius

The Company is addressing recommendations made by the FDA and anticipates initiating a Phase 2b clinical study in the first half of 2022.

Key Points: 
  • The Company is addressing recommendations made by the FDA and anticipates initiating a Phase 2b clinical study in the first half of 2022.
  • Halo-Lido is a proprietary topical formulation of halobetasol and lidocaine that is intended to provide symptomatic relief to individuals suffering from hemorrhoids.
  • We have worked closely with the FDA to design our Phase 2b study protocol and look forward to beginning the study in the coming months," stated Myron Holubiak, Chief Executive Officer of Citius.
  • The Phase 2b study is designed as a multi-center, randomized, dose-ranging, double-blind, parallel group comparison.

FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis

Retrieved on: 
Tuesday, September 21, 2021
Tablet, Food, Therapy, Miliaria, Rosacea, Irritation, Steroid, Hyperglycemia, Prevalence, BurNIng, Compliance, Itch, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Torso, FDA, Patient, Adolescence, Folliculitis, Body surface area, Scalp, Adult, Allergic contact dermatitis, Doxycycline, Immune system, Hypopigmentation, Glycosuria, Phase, CEO, Telangiectasia, Company, Ageing, Acne, Greasy hair, Dry, Hospira, ASX, Risk, Cushing's syndrome, Perioral dermatitis, Dermatology, Atrophy, Cell, Safety, Infection, Glaucoma, National Psoriasis Foundation, Ulobetasol, HPA, Time, Skin, Pharmaceutical industry, Cosmetics, Generic drug

LEXETTE, a super potent topical corticosteroid,is now approved for the treatment of plaque psoriasis in patients aged 12 years and older.

Key Points: 
  • LEXETTE, a super potent topical corticosteroid,is now approved for the treatment of plaque psoriasis in patients aged 12 years and older.
  • The FDA approved LEXETTE in 2018 based on evidence from two multicentre, randomized, double-blind, vehicle-controlled studies (n=560) in patients with plaque psoriasis involving between 2% to 12% body surface area.
  • LEXETTE (halobetasol propionate) foam is a potent corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve years of age and older.
  • LEXETTE foam was evaluated for the treatment of moderate to severe plaque psoriasis in two multicentre, randomised, double-blind, vehicle-controlled studies.

Sol-Gel Technologies Collaboration Partner Filed First-to-File Paragraph IV Certification for Duobrii®

Retrieved on: 
Thursday, September 3, 2020
Glucocorticoids, Organic compounds, Pharmaceutical companies, Chemistry, Perrigo, Ulobetasol propionate, Tazarotene, Ulobetasol, Food and Drug Administration

Development of halobetasol propionate and tazarotene lotion is covered under a previous collaboration betweenSol-GelandPerrigo.

Key Points: 
  • Development of halobetasol propionate and tazarotene lotion is covered under a previous collaboration betweenSol-GelandPerrigo.
  • If approved by the FDA, Perrigo will lead the commercialization efforts for the generic product candidate in the United States.
  • Sol-Gel and Perrigo will share the development costs and any gross profits generated from potential sales of the generic product candidate.
  • Annual market sales of Duobrii for the last 12 months ended July 2020 amounted to $88.4 million2.

FDA approves trade name Lexette(TM) (halobetasol propionate) foam, 0.05%

Retrieved on: 
Tuesday, April 30, 2019
Health, Medicine, Organ systems, Glucocorticoids, RTT, Food and Drug Administration, MedWatch, Psoriasis, Ulobetasol, Adverse effect

LEXETTE is a new formulation of halobetasol, a potent topical corticosteroid indicated for the treatment of plaque psoriasis in adult patients.

Key Points: 
  • LEXETTE is a new formulation of halobetasol, a potent topical corticosteroid indicated for the treatment of plaque psoriasis in adult patients.
  • The FDA approved halobetasol foam in May 2018 andMayne Pharma made the product available to US patients before it received a trade name.
  • Mayne Pharma's CEO, Mr Scott Richards said, "LEXETTE is an elegant foam formulation that will give psoriasis patents more treatment options.
  • To report SUSPECTED ADVERSE REACTIONS, contact at Mayne Pharma at 1-844-825-8500 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch .

Perrigo Announces Tentative FDA Approval For The First To File Generic Version Of Ultravate® Lotion 0.05%

Retrieved on: 
Monday, November 26, 2018
Chemistry, Glucocorticoids, Pharmacology, Health, Perrigo, Ulobetasol, Topical medication

DUBLIN, Nov. 26, 2018 /PRNewswire/ --Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration for the first to file generic version of Ultravate Lotion (halobetasol propionate) 0.05%.

Key Points: 
  • DUBLIN, Nov. 26, 2018 /PRNewswire/ --Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration for the first to file generic version of Ultravate Lotion (halobetasol propionate) 0.05%.
  • Perrigo previously announced a patent litigation suit with Sun Pharmaceutical Industries, Inc. and MiCal PharmaceuticalsLLC for this product.
  • Ultravate Lotion, 0.05% is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
  • Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providingQuality Affordable Healthcare Products.

Bausch Health's Ortho Dermatologics Business To Present New Scientific Data During The Fall Clinical Dermatology Conference

Retrieved on: 
Monday, October 15, 2018
Chemistry, Glucocorticoids, Organic chemistry, Dermatology, Bausch Health, S&P/TSX 60 Index, Ulobetasol propionate, Tazarotene, Ulobetasol, Psoriasis

LAVAL, Quebec, Oct. 15, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of 16 posters during the Fall Clinical Dermatology Conference in Las Vegas, Oct. 18-21.

Key Points: 
  • LAVAL, Quebec, Oct. 15, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of 16 posters during the Fall Clinical Dermatology Conference in Las Vegas, Oct. 18-21.
  • "We are committed to researching and bringing forward innovative dermatology treatment options for the patients we serve," said Bill Humphries, president, Ortho Dermatologics.
  • The complete list of all poster presentations that will include Ortho Dermatologics products and pipeline programs during the meeting is as follows.
  • "Long-Term Management of Moderate-to-Severe Plaque Psoriasis: Maintenance of Treatment Success Following Cessation of Fixed Combination Halobetasol Propionate 0.01% and Tazarotene 0.045% (HP/TAZ) Lotion."

Bausch Health's BRYHALI™(halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults

Retrieved on: 
Monday, October 8, 2018
Glucocorticoids, Chemistry, Psoriasis, Immunology, Organic chemistry, RTT, Ulobetasol propionate, Ulobetasol, Topical steroid

BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion.

Key Points: 
  • BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion.
  • 1 The final FDA approval for BRYHALI Lotionis pending the expiration of exclusivity for a related product, which is expected in early November 2018.
  • "Just as every psoriasis patient's journey is different, so too are their treatment needs, which is why psoriasis is a key therapeutic focus for our business.
  • The trials were conducted in a total of 430 subjects who were 18 years of age and older with moderate to severe plaque psoriasis.