In Dermatology, assessment of people of color remains underrepresented in RCTs (<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420

Start Date01 Jul 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nice

NCT06698263

/ Not yet recruitingPhase 4IIT

13-cis Retinoic Acid (Isotretinoin) and Sperm Production

This study aims to evaluate the effectiveness of weekly administration of isotretinoin (40 mg) in increasing sperm production in men with oligozoospermia, a condition characterized by a low sperm count. Participants will be randomized into two groups: one receiving isotretinoin and the other a placebo. The primary outcome will be the change in sperm production over 20 weeks of treatment.

Start Date01 Mar 2025

Sponsor / Collaborator

Les Hopitaux Universitaires de Strasbourg

NCT06225570

/ RecruitingEarly Phase 1IIT

Randomized Controlled Trial of Weekly Oral Isotretinoin vs. Oral Tetracyclines for the Treatment of Moderate Acne Vulgaris

In the effort to find better treatments for Moderate Acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While Isotretinoin, a Vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly Isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly Isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, investigators propose a randomized controlled trial comparing weekly Isotretinoin to daily Doxycycline over four months. This study could confirm the safety and effectiveness of weekly Isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.

Start Date01 Feb 2025

Sponsor / Collaborator

The Medical University of South Carolina

100 Clinical Results associated with Isotretinoin

100 Translational Medicine associated with Isotretinoin

100 Patents (Medical) associated with Isotretinoin

7,047

Literatures (Medical) associated with Isotretinoin

01 Jun 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Emodin-8-O-β-D-glucopyranoside alleviates cholestasis by maintaining intestinal homeostasis and regulating lipids and bile acids metabolism in mice

Article

Author: Li, Jie ; Zhang, Xuemei ; Ocholi, Simon Sani ; Han, Lifeng ; Yu, Qiao ; Wang, Liming ; Yan, Ziping ; Hou, Yuzhao ; Wu, Xiaolin

Cholestatic liver disease(CLD) is caused by impaired bile flow due to obstruction of the biliary tract, and long-term exposure to bile acids in the liver triggers inflammation, eventually leading to liver toxicity and liver fibrosis. Emodin-8-O-β-D-glucopyranoside(EG) is anthraquinone compound that is widely found in traditional Chinese medicine. It possessed antioxidative and anti-inflammatory activities. However, the effect of EG on cholestatic liver injury(CLI) has not been explored. In this study, Alpha-naphthyl isothiocyanate(ANIT)-induced CLI mice were used to investigate the anti-cholestasis and hepatoprotective effects of EG through serum biochemical index detection, non-targeted metabolomics, lipidomics, and intestinal flora 16S rRNA sequencing. The results suggested that EG restores homeostasis of the gut microbiome while regulating bile acids metabolism and lipid-related metabolic pathways to reduce liver damage in ANIT-induced cholestasis. This study provides a new perspective on the mechanism of EG, and help offer a more natural approach to managing liver damage.

01 Apr 2025·PLASTIC AND RECONSTRUCTIVE SURGERY

Dispelling the Myths of Isotretinoin and Implications for Rhinoplasty

Review

Author: Blough, Jordan T. ; Wyles, Saranya P. ; Rohrich, Rod J. ; Rohrich, Rachel N.

Summary::

Despite concerns from 1980s case reports, oral isotretinoin, a derivative of vitamin A, has largely proven to be safe in surgical procedures, with the exception of deep skin resurfacing. Isotretinoin modulates thinning skin and internal scarring in select rhinoplasty patients who may otherwise have poor definition and excessive scarring. A review of patients undergoing surgical interventions, including rhinoplasty, in the setting of concomitant isotretinoin use was performed to examine safety and therapeutic potential. A total of 49 studies were reviewed. Isotretinoin use appears to be safe in a wide variety of surgical procedures relying on internal scar formation. In rhinoplasty, oral isotretinoin was used to thin skin and improve appearance, and resulted in patient and surgeon satisfaction. As such, the clinical potential for using oral isotretinoin in select rhinoplasty candidates—such as those with thick, glaborous, sebaceous skin; male sex; certain races or ethnicities; or revision cases—could mitigate internal scarring processes. Further studies examining the optimal dosing regimen and long-term benefits are warranted.

01 Apr 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Low‐dose isotretinoin for the management of rosacea: A systematic review and meta‐analysis

Review

Author: Tan, Marcus G. ; Kirshen, Carly ; Tolkachjov, Stanislav N. ; King, Aliyah

Abstract:

Background:

Rosacea is a chronic, relapsing inflammatory dermatosis predominantly affecting the central face and can result in significant psychosocial impacts. Isotretinoin has been studied for rosacea due to its anti‐inflammatory and sebum reduction properties, but its use remains limited likely due to its off‐label use and potential adverse events.

Objective:

This systematic review and meta‐analysis investigated the efficacy and safety of low‐dose isotretinoin (LDI; ≤0.5 mg/kg/day) for the four main types of rosacea: erythematotelangiectatic, papulopustular, phymatous and ocular rosacea.

Methods:

Randomized and non‐randomized studies evaluating LDI for rosacea were included. Incomplete studies, non‐English studies and case reports were excluded. Study quality was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation scale.

Results:

Of 435 studies, and 16 studies involving 1445 patients were included. LDI decreased lesion count (p = 0.03) and erythema (p = 0.01) with large effect [standardized mean difference (SMD) > 0.8]. Compared to topical retinoids and topical antimicrobials, isotretinoin had larger reductions in lesion count (p = 0.03) with moderate effect (SMD > 0.5). Mean lesion count and erythema remained reduced by 70% and 47%, respectively, at 16 weeks after LDI cessation. Relapse rate was 35% at 5.5 months post‐isotretinoin, and three patients (0.4%) experienced worsening of rosacea. Three patients (0.4%) experienced serious adverse events.

Conclusions:

Study design heterogeneity limited more comprehensive comparisons. Overall, low‐dose isotretinoin may serve as an effective treatment for rosacea with good tolerability and safety.

News (Medical) associated with Isotretinoin

26 Mar 2025

·ir.journeymedicalcorp.com

Journey Medical Corporation Reports Full-Year 2024 Financial Results and Recent Corporate Highlights

FDA Approval of Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules) for Rosacea Emrosi Initial Distribution Ongoing; First Prescriptions Filled Total Revenues for the Full Year Ended December 31, 2024 were $56.1 million Met All Financial Guidance for 2024 Emrosi Phase 3 Clinical Trial Results Published in JAMA Dermatology Company to Hold Conference Call Today at 4:30 p.m. ET SCOTTSDALE, Ariz., March 26, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”) approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the full year ended December 31, 2024. Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “We delivered a solid performance in 2024, meeting all of our financial guidance ranges and received first cycle FDA approval for Emrosi™ in November, ahead of the scheduled PDUFA date. Emrosi’s superb Phase 3 clinical results demonstrated its best-in-class profile, and we expect it will become the standard of care and transform our business. Our cash position remains strong ahead of Emrosi’s launch and our objective is to deliver enhanced revenue growth and become sustainably EBITDA positive. I am pleased to report that we have begun distribution of Emrosi, that first prescriptions have been dispensed and that we continue to execute ahead of schedule, with full promotion expected in April 2025.” 2024 Financial Guidance: 2024 Financial Results: Total revenues were $56.1 million for the full year 2024 compared to $79.2 million for the full year of 2023. Product revenue, net decreased $4.5 million, or 8%, to $55.1 million for 2024, from $59.7 million for 2023, due to overall higher rebates costs across the Company’s product portfolio and lower unit sales volumes, mainly from our legacy products. Increases in unit sales volumes for Qbrexza® and Accutane® were offset by higher rebate costs. Other revenue for 2023 reflects a one-time upfront license payment of $19.0 million and $0.5 million in product related royalties for Qbrexza from Maruho Ltd., our exclusive licensing partner in Japan. 2024 reflects a $1.0 million milestone payment pursuant to Journey’s license agreement with Cutia Therapeutics (HK) Limited (“Cutia”) that became payable to us upon Cutia receiving marketing approval for Amzeeq® in the People’s Republic of China. Cost of goods sold (“COGS”) decreased by $2.0 million, or 9%, to $20.9 million for 2024, from $22.9 million for 2023 due to a decrease in product royalties, stemming from the contractual royalty decreases in 2023 and the discontinuation of Ximino. The Company’s gross margin percentage slightly improved from period-to-period, as the cost savings noted above were partially offset by higher product COGS. SG&A expenses decreased by $3.7 million, or 8%, to $40.2 million for 2024, from $43.9 million for 2023. The decrease is mainly due to expense reduction efforts primarily in sales and marketing, partially offset by increases in non-cash share-based compensation expense, Emrosi launch expenses, and increased SG&A related to the expansion of our market access and coverage platforms. R&D expenses were $9.9 million for 2024, compared to $7.5 million for 2023. R&D expenses for 2024 include a $4.1 million application filing fee payment to the FDA for Emrosi, and a $3.0 million milestone payment triggered by the FDA’s acceptance of the Company’s NDA application for Emrosi. Clinical trial expenses were significantly lower than 2023, as clinical development for Emrosi concluded in 2024. The Company’s net loss was $(14.7) million, or $(0.72) per share basic and diluted for the full year 2024, compared to the net loss of $(3.9) million or $(0.21) per share basic and diluted for the full year 2023. Net loss for 2023 includes revenue from the Maruho upfront fee license payment of $19.0 million and $0.5 million in product related royalties. The Company’s non-GAAP results in the table below reflect Adjusted EBITDA of $0.8 million, or $0.04 per share basic and $0.03 per share diluted for the full year 2024. This compares to Adjusted EBITDA of $15.6 million, or $0.85 per share basic and $0.75 per share diluted for the full year 2023. Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are non-GAAP financial measures, each of which are reconciled to the most directly comparable financial measures calculated in accordance with GAAP below. At December 31, 2024, Journey Medical’s cash and cash equivalents totaled $20.3 million, compared to $22.5 million on September 30, 2024, and $27.4 million on December 31, 2023, a decrease of $2.2 million for the quarter and a decrease of $7.1 million from the prior-year period. Recent Corporate Highlights: In March 2025, Journey Medical announced publication in the Journal of the American Medical Association - Dermatology of the Phase 3 clinical trial results of Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) to treat rosacea. Emrosi achieved the co-primary and all secondary endpoints with no significant safety issues when administered once daily for 16 weeks. In February 2025, Journey Medical hosted a conference call and webcast to discuss its U.S. commercial launch plan for Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules) for the treatment of rosacea. A replay of the webcast is available on the IR calendar page of the Journey Medical website, here. In November 2024, the U.S. FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in adults. In October 2024, clinical data were presented at the 44th Fall Clinical Dermatology Conference assessing the dermal and systemic pharmacokinetics of Emrosi versus oral Doxycycline 40 mg capsules (Oracea®)1 in healthy subjects. In July 2024, Journey Medical appointed Michael C. Pearce to its Board of Directors. Mr. Pearce is an accomplished executive, with substantial strategic, business and financial expertise across many industries, including healthcare. In April 2024, Journey Medical appointed Joseph M. Benesch as its permanent Chief Financial Officer. Mr. Benesch served as Journey Medical’s Interim Chief Financial Officer since January 2023 and previously, he was Corporate Controller at the Company since November 2021. Conference Call and Webcast InformationJourney Medical management will conduct a conference call and audio webcast on March 26, 2025, at 4:30 p.m. ET. To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register for the conference here: https://dpregister.com/sreg/10197674/feaf5b7354. Please note that registered participants will receive their dial-in number upon registration. A live audio webcast can be accessed on the News and Events page of the Investors section of Journey Medical’s website, www.journeymedicalcorp.com, and will remain available for replay for approximately 30 days after the meeting. (1) Oracea® is a registered trademark of Galderma Holdings, S.A. Société Anonyme. About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets eight FDA approved prescription drugs that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. 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 include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, Emrosi™, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. 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 may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact:Jaclyn Jaffe (781) 652-4500ir@jmcderm.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com Use of Non-GAAP Measures: In addition to the GAAP financial measures as presented in our Form 10-K that will be filed with the Securities and Exchange Commission (“SEC”), the Company has, in this press release, included certain non-GAAP measurements, including Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted. We define Adjusted EBITDA as net income (loss) excluding interest, taxes and depreciation and amortization, less certain other non-cash and infrequent items not considered to be normal, recurring operating expenses, including, share-based compensation expense, amortization and impairments of acquired intangible assets, severance, short-term research and development expense and foreign exchange transaction losses. In particular, we exclude the following matters for the reasons more fully described below: Share-Based Compensation Expense: We exclude share-based compensation from our adjusted financial results because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Gain on Extinguishment of Debt: We exclude the gain on extinguishment of debt to settle amounts owed as part of license installment payments, because we consider this to be a non-cash, non-recurring item. Short-Term Research and Development Expense: We exclude research and development costs incurred in connection with Emrosi, formerly referred to as DFD-29, including the filing fee payment made to the FDA and contractual milestone payments, which was the only product in our portfolio not approved for marketing and sale during the reporting period, because we do not consider such costs to be normal, recurring operating expenses that are core to our long-term strategy. Instead, our long-term strategy is focused on the marketing and sale of our core FDA-approved dermatological products and out licensing our intellectual property and related technologies. Amortization and Impairments of Acquired Intangible Assets: We exclude the impact of certain amounts recorded in connection with the acquisitions of intangible assets that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. These amounts may include non-cash items such as the amortization impairments of acquired intangible assets. Loss Recovery: We exclude the loss recovery payment because we consider this to be a one-time, non-recurring source of income. Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are determined by dividing the resulting Adjusted EBITDA by the number of shares outstanding on an actual and fully diluted basis. Management believes the use of these non-GAAP measures provide meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making, (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance and (iii) it is used by institutional investors and the analyst community to help analyze the Company's results. However, Adjusted EBITDA, Adjusted EBITDA per share basic, Adjusted EBITDA per share diluted and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors. The table below provides a reconciliation from GAAP to non-GAAP measures: Released March 26, 2025

Phase 3Executive ChangeFinancial StatementClinical ResultDrug Approval

07 Mar 2025

·www.prnewswire.com

TRANSFORM YOUR SKIN HEALTH: DIET AND LIFESTYLE TAKE CENTER STAGE AT 2025 AAD ANNUAL MEETING

ORLANDO, Fla., March 7, 2025 /PRNewswire/ -- The 2025 American Academy of Dermatology Annual Meeting will take place March 7-11 in Orlando. The meeting will feature nearly 300 educational sessions with more than 1,700 speakers discussing the latest research on skin, hair, and nails, including topics on how diet and lifestyle can transform skin health, eczema management, and insights into aging skin. A New Era in Skin Health: GLP-1 Medications Your skin is often a window to your overall health, including underlying inflammatory and metabolic conditions. New treatments, like GLP-1 medications commonly used for weight loss, can help manage obesity, reduce inflammation, and improve skin conditions, highlighting how board-certified dermatologists are advancing personalized care. Inflammation and Skin Conditions Are Linked: Obesity often causes inflammation that can worsen or trigger skin conditions like psoriasis, eczema, and hidradenitis suppurativa, a chronic disease that causes painful lumps to form under the skin. GLP-1 Medications and Your Skin: While originally developed to treat diabetes and, more recently, promote weight loss, GLP-1 medications can reduce inflammation caused by obesity and improve certain skin conditions. A New Era of Dermatology: Treating conditions like obesity can bring about a healthier 'you' and help skin treatments work better, leading to more complete care. Lindsey Bordone, MD, FAAD, an assistant professor of dermatology at Columbia University Department of Dermatology, can discuss the connection between obesity and skin health, and how addressing your overall health can benefit your skin and well-being. The Role of Diet in Managing Eczema Many people believe that food is the root cause of atopic dermatitis, commonly known as eczema, which can result in dry, itchy skin. However, the relationship between diet and this common skin condition is more complex than it seems. New research is shedding light on how diet influences eczema – which affects nearly one in ten Americans – and empowers patients to make more informed choices. Cutting Foods Isn't a Cure-All: For most patients, simply eliminating certain foods doesn't significantly improve eczema symptoms, despite common misconceptions. The Role of a Healthy Diet: Emphasizing overall healthy eating and avoiding allergens can still play an important role in managing eczema. Early Allergen Introduction: Introducing allergenic foods early in life may help build tolerance, offering a powerful shift in how people manage their eczema. Peter A. Lio, MD, FAAD, a clinical assistant professor of dermatology at Northwestern Medicine in Chicago, can provide evidence-based strategies for managing eczema through diet and lifestyle. How Diet Can Enhance the Effectiveness of Skin Treatments The foods you eat play a vital role in how well medications work for skin conditions and can even help to minimize possible side effects. By making thoughtful dietary choices, you can support your skin health, maximize the effectiveness of treatments for skin disease, and improve your overall health. Optimize Treatment with Nutrition: The Mediterranean diet, which encourages people to eat plant-based foods, and omega-3 fats, can help make biologic treatments for psoriasis more effective, while also reducing heart disease risks associated with this common skin condition. Support Immunotherapy with Fiber: For advanced melanoma, the deadliest form of skin cancer, a diet rich in fiber from fruits, vegetables, and whole grains enhances the effectiveness of immunotherapy, a cancer treatment that uses the patient's own immune system to fight the disease. At the same time, patients should avoid probiotic supplements, which can make treatments less effective. Complement Therapy with Supplements: For those who suffer from acne, omega-3 supplements improve the absorption of isotretinoin, a common acne medication, and minimize its side effects. Steven Daveluy, MD, FAAD, an associate professor of dermatology at Wayne State University in Dearborn, Michigan, details how your diet can work alongside your treatment plan for healthier skin and a healthier you. Understanding Itch: A Window into Aging Skin Itch is the most common symptom for which patients over 50 visit a dermatologist. Importantly, recent scientific breakthroughs and treatment innovations are revolutionizing dermatologists' understanding and management of this condition. More than a symptom, itch offers valuable insights into how the immune system, nervous system, and skin barrier – the outermost layer of skin that serves as a protective shield for the body – change as we age. Increasingly More Common and Severe: Itch becomes more common and severe with age, significantly impacting quality of life, including sleep, daily activities, and our ability to care for others. Complicated Causes in Older Adults: Diagnosing the cause of itch in older adults is harder because visual signs and lab clues are less definitive. This can result in undertreatment. Evolving Treatments: While there are no FDA-approved medications specifically for itch, dermatologists have a variety of treatments at hand to address its effects, including moisturizers as well as topical ointments, phototherapy, biologics – which target diseases throughout your body and neurologic treatments like nerve creams and oral medications. Daniel C. Butler, MD, FAAD, an assistant dean and an associate professor of dermatology at University of Arizona College of Medicine in Tucson, can discuss the types of personalized treatment options dermatologists recommend for patients who struggle with persistent itch. If you have questions about a skin, hair, or nail condition, consult a board-certified dermatologist to ensure you receive trusted, expert guidance tailored to your needs. About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 21,000 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow @AADskin on Facebook, Pinterest, and YouTube, and @AADskin1 on Instagram. SOURCE American Academy of Dermatology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

07 Jan 2025

·www.prnewswire.com

Norgine submits Marketing Authorisation Application to the European Medicines Agency for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma

Back to media releases Next media release LONDON, Jan. 7, 2025 /PRNewswire/ -- Norgine today announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB). This follows the submissions in April 2024, via Project Orbis, in Australia, Switzerland and the United Kingdom. This milestone further supports Norgine's efforts to give patients access to eflornithine and bring a further treatment option in the field of paediatric oncology. Norgine and USWM, LLC (dba US WorldMeds), a Kentucky-based specialty pharmaceutical company, have an exclusive licensing agreement by which Norgine will register and commercialise eflornithine, also referred to as DFMO, in Europe, Australia and New Zealand. On 13 December 2023, the US Food and Drug Administration (FDA) approved eflornithine as the first oral maintenance therapy for HRNB, indicated to reduce the risk of relapse in adult and paediatric patients who have received certain prior therapies.[1] The approval decision was based on findings from a trial comparing outcomes from patients treated with eflornithine in Study 3b (NCT02395666)[2],[4] to control patients derived from Study ANBL0032 (NCT00026312; clinical-trial-derived external control arm)[3],[4]. The study with eflornithine treated patients showed improved event-free survival and overall survival when compared to outcomes for patients with HRNB treated with the standard of care (SoC).[1] Dr David Gillen, Chief Medical Officer at Norgine, added, "This submission via the EU Centralised Procedure represents another important step in the regulatory process for eflornithine and further emphasises Norgine's passion and commitment in attempting to secure additional treatment options for patients living with HRNB, a condition with a high level of unmet medical need." Janneke van der Kamp, CEO of Norgine added "Submitting this marketing authorisation to the EMA marks a pivotal step for patients facing this challenging cancer. We are committed to advancing innovative therapies that address the unmet needs of young patients and their families, and this milestone brings us closer to offering hope where it's most needed". Follow @norgine Notes to Editors: HRNB background Children diagnosed with HRNB undergo an intense SoC regimen that still leaves them vulnerable to relapse and death, a risk that is highest for the first two years after completing treatment.[5] Approximately 30% of patients who attain remission following upfront therapy will relapse, and once relapsed, mortality significantly increases with a post-relapse 4-year overall survival of under 10%.[5], [6] Therefore, avoiding relapse is key to long-term survival, yet outside of the United States there are no approved therapies for sustaining remission following SoC treatment. The data demonstrate that using eflornithine after completion of upfront SoC treatment, as post-maintenance therapy extends remission and reduces risk of relapse in patients with HRNB. About Norgine Norgine is a uniquely positioned, specialty pharmaceutical and consumer healthcare company, with over €500 million of annual revenues and a 120-year track record of bringing life-changing products to patients and consumers across our core markets of Western Europe, Australia and New Zealand. Our integrated approach – strong commercial capabilities, deep medical, regulatory and clinical expertise, in-house manufacturing, robust supply networks, and best in class enabling functions – ensures that we can deliver high-quality, transformative medicines quickly and effectively to over 25 million patients annually. Today's Norgine is a nimble, innovative, and high-performing company that has been transformed by a relentless focus on operational excellence. This focus will enable us to secure the legacy of more than a century of innovation and doing the right thing by our patients, as we push the boundaries and take strides into new therapeutic areas. NORGINE and the sail logo are trademarks of the Norgine group of companies. References FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma. FDA. News release. 13 December 2023. Available from: FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | FDA Clinical Trial NCT02395666; Preventative trial of difluoromethylornithine (DFMO) in high risk patients with neuroblastoma that is in remission. Available from: Study Details | Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission | ClinicalTrials.gov. Clinical Trial NCT00026312; Isotretinoin with or without dinutuximab,[1] aldesleukin, and sargramostim following stem cell transplant in treating patients with neuroblastoma. Available from: Study Details | Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma | ClinicalTrials.gov Oesterheld J, Ferguson W, Kraveka JM, Bergendahl G, Clinch T, Lorenzi E et al. Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons. 2024; 42 (1): 90-102. Basta NO, Halliday GC, Makin G, Birch J, Feltbower R, Bown N, et al. Factors associated with recurrence and survival length following relapse in patients with neuroblastoma. Br J Cancer. 2016;115:1048-57. London WB, Bagatell R, Weigel BJ, Fox E, Guo D, Van Ryn C, et al. Historical time to disease progression and progression-free survival in patients with recurrent/refractory neuroblastoma treated in the modern era on Children's Oncology Group early-phase trials. Cancer. 2017;123:4914-23.[2] Job code: UK-ONC-NP-2400019 Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug Approval

100 Deals associated with Isotretinoin

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KEGG	Wiki	ATC	Drug Bank
D00348	Isotretinoin	D10BA01 D10AD04	DB00982

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Acne Vulgaris	Canada	Sun Pharmaceutical Industries Ltd.	22 Jun 2023
Cystic acne	Australia	Roche Products Pty Ltd.	05 Dec 1994
Acneiform Eruptions	United States	Hoffmann-La Roche, Inc.	07 May 1982

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autosomal recessive ichthyosis	Phase 3	United States	-	21 Jun 2022
Autosomal recessive ichthyosis	Phase 3	Canada	-	21 Jun 2022
Autosomal recessive ichthyosis	Phase 3	France	-	21 Jun 2022
Autosomal recessive ichthyosis	Phase 3	Germany	-	21 Jun 2022
Autosomal recessive ichthyosis	Phase 3	Italy	-	21 Jun 2022
Ichthyosis, X-Linked	Phase 3	United States	-	21 Jun 2022
Ichthyosis, X-Linked	Phase 3	Canada	-	21 Jun 2022
Ichthyosis, X-Linked	Phase 3	France	-	21 Jun 2022
Ichthyosis, X-Linked	Phase 3	Germany	-	21 Jun 2022
Ichthyosis, X-Linked	Phase 3	Italy	-	21 Jun 2022

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03076021 (CTgov)	Phase 4	-	33	isotretinoin (Pre-isotretinoin)	hxxrqawkes(qggcshzkwj) = zkbdpxfmvz vzzdpzgjjz (xykndkgzeg, bjqgzvsqut - qscpheegys) View more	-	28 Jan 2025
				Isotretinoin (With Isotretinoin)	hxxrqawkes(qggcshzkwj) = gcjkrjogqt vzzdpzgjjz (xykndkgzeg, jgdrizhtvy - jmexhybbju) View more
NCT05295732 (ASCEND, NEWS) Manual	Phase 3	Ichthyosis	-	-	jcjvxlhdco(pjhxpplauh) = not met ovlkuwscnv (awxkhskikv ) Not Met View more	Negative	22 Aug 2024
				-
EULAR2024	Not Applicable	Low Back Pain	-	Isotretinoin use for acne vulgaris	mpffyerzss(cgchqtoitz) = 59 patients who developed inflammatory low back pain after isotretinoin use were included meswtrreuz (cqnfiygxbp ) View more	-	05 Jun 2024
EADV2023	Not Applicable	Acne Vulgaris	1,191	Surgical extraction + Isotretinoin	ndcabwkino(vepfexjmtq) = gbdwzrwnmg ngxkzmzdai (ptlxdedwex ) View more	Positive	11 Oct 2023
EADV2023	Not Applicable	Irritable Bowel Syndrome \| Inflammatory Bowel Diseases	-	Isotretinoin	zqxwslwprb(pupvxtifas) = seocuicois ixcmoxfbjg (tmlctfunbm, 2.5 - 7.7)	Positive	11 Oct 2023
EADV2023	Not Applicable	-	-	Isotretinoin	qwolcsczpa(ovtxjqwbyc): HR = 0.82 (95% CI, 0.77 - 0.87), P-Value = <0.001 View more	Positive	11 Oct 2023
				Oral antibiotics
THU376 (ENDO2023)	Not Applicable	Diabetes Mellitus, Type 2	-	Isotretinoin	hhkxqyyokb(dnaksklttz) = presented with hyperglycemia, acidosis, hypertriglyceridemia, elevated anion gap, low bicarbonate, and elevated ketones dyhgsuvrxn (ubsdrvnwdl ) View more	Positive	05 Oct 2023
				Basal-bolus insulin
WCD2023	Not Applicable	Pustular psoriasis	-	Isotretinoin	jxdhgyahzg(mjyrhkbske) = tsnaucmfss izpahnglse (bktjyburtt )	-	03 Jul 2023
WCD2023	Not Applicable	Acne Vulgaris	30	Isotretinoin + SOD	fgoanewbqv(lzqdtyjeyy) = nxkvqckmkr gohcsfaxjv (bgqnspbpdj )	Positive	03 Jul 2023
COG ALTE15N2—LEAHRN (ASCO2023) Manual	Not Applicable	High Risk Neuroblastoma	375	chemotherapy + radiation + isotretinoin + anti-GD2 antibody therapy + MIBG + single or tandem ASCT(Busulfan/Melphalan (BuMel), Carboplatin/Etoposide/Melphalan (CEM), Thiotepa/Cytoxan,Busulfan/Melphalan (BuMel), Carboplatin/Etoposide/Melphalan (CEM), Thiotepa/Cytoxan, and total body irradiation	kloiajfune(lezrkmzaor) = isjgwvjjio vfnoyzdcbx (hkmxmnadpk ) View more	Negative	31 May 2023
				single Carboplatin/Etoposide/Melphalan (CEM)Carboplatin/Etoposide/Melphalan (CEM)	-

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