Comparative analysis of tapered short course deflazacort and acetaminophen versus acetaminophen in treatment of early stage periarthritis of shoulder in adults.

Start Date06 Feb 2022

Sponsor / Collaborator-

CTRI/2021/08/035475 / Not yet recruitingPhase 4IIT

Evaluation of the Efficacy and Safety of Deflazacort in Stone Clearance after Extracorporeal Shockwave Lithotripsy when used along with Oral Hydration and Alpha Blockers â?? A Randomized Clinical Trial

Start Date10 Aug 2021

Sponsor / Collaborator-

100 Clinical Results associated with Deflazacort

100 Translational Medicine associated with Deflazacort

100 Patents (Medical) associated with Deflazacort

537

Literatures (Medical) associated with Deflazacort

01 Sep 2024·FISH & SHELLFISH IMMUNOLOGY

The alleviation of difenoconazole-induced kidney injury in common carp (Cyprinus carpio) by silybin: Involvement of inflammation, oxidative stress, and apoptosis

Article

Author: Yang, Lanqing ; Li, Xing ; Xia, Xinyu ; Xu, Linyu ; Wu, Qiuyue ; Chen, Yang ; Li, Mengxin ; Dong, Jingquan

Triazole fungicides, such as difenoconazole (DFZ), are frequently used to control fungus in crops that pollute water. The common carp (Cyprinus carpio) (hereafter referred to as "carp") is an excellent bio-indicator of water quality. The seeds of the silymarin plant contain a flavonolignan called silybin (SYB), which is used to treat liver disease. To explore SYB's involvement in DFZ-triggered kidney damage in carps, an H&E assay was conducted, and ROS level was also examined. The results demonstrated that SYB alleviated DFZ-induced destruction of kidney tissue structure in carps, as well as alleviating the elevation of kidney ROS level in carps. RT-qPCR and Western blot were used to detect inflammation-, oxidative stress- and apoptosis-related factors at mRNA level and protein level. The experimental findings indicated that relative to the DFZ group, SYB + DFZ co-treatment reduced inflammation-related mRNA level of il-6, il-1β and tnf-α, elevated mRNA level of il-10. It also reduced protein expression levels of NF-κB and iNOS. In addition, SYB + DFZ co-treatment reduced DFZ-induced increase in the oxidative stress-related mRNA indicators sod and cat, and decreased the protein expression levels of Nrf2 and NQO1. SYB reduced the DFZ-induced increase in pro-apoptotic gene Bax mRNA and protein expression levels and the DFZ-induced decrease in anti-apoptotic gene Bcl-2 mRNA and protein expression levels. In summary, SYB potentially mitigates DFZ-induced kidney damage in carp by addressing inflammation, oxidative stress, and apoptosis. Our results establish a theoretical foundation for the clinical advancement of freshwater carp feeds.

01 Aug 2024·FISH & SHELLFISH IMMUNOLOGY

Protective effect of feed additive ferulic acid on respiratory depression and oxidation imbalance of carp induced by pesticide difenoconazole via ROS/NF-κB/NLRP3 axis

Article

Author: Yan, Weiping ; Ji, Guangquan ; Li, Yuanyuan ; Li, Mengxin ; Xiang, Yannan ; Li, Ying ; Pan, Enzhuang ; Dong, Jingquan

Difenoconazole (DFZ), classified as a "low-toxicity pesticide," has seen widespread application in recent years. Nevertheless, the non-target toxicity of the substance, particularly towards aquatic creatures, has generated considerable apprehension. The anti-inflammatory and antioxidant effects of Ferulic Acid (FA) have attracted considerable study in this particular setting. This study established a chronic exposure model to DFZ and investigated the protective effects of FA on chronic respiratory inhibition leading to gill damage in freshwater carp. Histological analyses via HE staining indicated that FA effectively alleviated gill tissue damage induced by chronic DFZ exposure. The qRT-PCR results showed that the addition of FA reduced the expression of IL-1β, IL-6 and TNF-α while boosting the expression of IL-10 and TGF-β1. Biochemical analyses and DHE staining revealed that FA reduced MDA levels and increased CAT and GSH activities, along with T-AOC, decreased ROS accumulation in response to chronic DFZ exposure. The results obtained from Western blotting analysis demonstrated that the addition of FA effectively suppressed the activation of the NF-κB signalling pathway and the NLRP3 inflammasome pathway in the gills subjected to prolonged exposure to DFZ. In summary, FA ameliorated gill tissue inflammation and blocked ROS accumulation in carp exposed to chronic DFZ, mitigating tissue inflammation and restoring redox homeostasis through the NF-κB-NLRP3 signaling pathway. Hence, the application of FA has been found to be efficacious for improving respiratory inhibition and mitigating gill tissue inflammation and oxidative stress resulting from DFZ pollution in aquatic habitats.

05 Jul 2024·MEDICINE

Case report of an unusual allergic reaction to a routine skin prick test performed in an outpatient clinic: Diagnosis, management, and knowledge gaps

Article

Author: Cherrez-Ojeda, Ivan ; Robles-Velasco, Karla ; Mosnaim, Giselle ; Fok, Jie Shen ; Cevallos-Levicek, Denisse

Background::

The skin prick test (SPT) is a standard procedure in allergy/immunology clinics, crucial for evaluating conditions like allergic rhinitis and food allergies. As a cornerstone in investigating immunoglobulin E-mediated allergy, it plays a vital role in diagnosing allergies, including those triggered by common dust mites like Dermatophagoides pteronyssinus, Dermatophagoides farinae, Euroglyphus maynei, and Blomia tropicalis. Despite its widespread use, adverse reactions to SPT are uncommon (15 per 100,000 patients), though the procedure is not entirely risk-free. This article presents a clinical case involving a 17-year-old female who experienced a moderately delayed allergic reaction 120 minutes post-SPT, managed effectively with subsequent symptom resolution.

Methods::

The patient, with a history of persistent rhinorrhea, itchy nose, eyes, and postnasal drip, sought consultation due to worsening symptoms. Diagnostic measures, including patient-reported outcomes and SPT with a standard aeroallergen panel, revealed sensitization to various allergens.

Results::

Post-test, the patient reported ocular pruritus, left eyelid swelling, and moderate rhinorrhea, persisting for about 24 hours. On the subsequent medical visit, the patient received rupatadine and deflazacort, leading to symptom resolution within 3 hours.

Conclusion::

This article delves into a systemic allergic reaction post-SPT, emphasizing the 2 main stages of type I hypersensitivity reactions. While the acute phase involves mast cell-driven mediators within 15 minutes, the delayed phase (4–8 hours) includes de novo cytokine release. Vigilance regarding symptom onset and differentiation between mild and severe reactions is crucial. Notably, the absence of specific waiting time guidelines post-SPT underscores the need for reporting to enhance understanding and subsequent management. Performing these procedures in specialized centers with qualified professionals is essential for effectively managing potential anaphylactic reactions. Addressing these knowledge gaps will contribute to enhanced patient safety during diagnostic procedures.

News (Medical) associated with Deflazacort

17 Jun 2024

·www.prnewswire.com

Pfizer's Setback in Duchenne Muscular Dystrophy Treatment Trial Clears Path for Sarepta, and Many Other Pharma Companies | DelveInsight

Pfizer's mini-dystrophin gene therapy fordadistrogene movaparvovec failure in the Duchenne muscular dystrophy treatment opens new opportunities for several pharmaceutical companies such as Sarepta Therapeutics (SRP-5051), Santhera Pharmaceuticals/ReveraGen BioPharma (Vamorolone), Taiho Pharmaceutical (TAS-205), FibroGen (Pamrevlumab), and others, to advance their therapies and potentially dominate the DMD market. LAS VEGAS, June 17, 2024 /PRNewswire/ -- Duchenne muscular dystrophy is the most prevalent type of muscular dystrophy found in children. This genetic condition leads to ongoing muscle weakening and degeneration. It is one among nine different forms of muscular dystrophy. According to DelveInsight's estimates, the US accounted for around ~17K total prevalent cases of Duchenne muscular dystrophy in 2023. The highest cases were found in the children of the 5-9 age group, these numbers are expected to grow by the year 2034. As per DelveInsight's analysis, the most commonly associated comorbidities accompanied with DMD included the highest cases of scoliosis accounting for around ~20% of cases followed by ADHD, cardiomyopathy, and obsessive-compulsive disorders accounting for around ~19%, ~18%, and ~15% cases respectively in the US in the year 2023. The standard of care for DMD typically involves a combination of corticosteroids and surgical interventions. Prednisone and deflazacort are commonly prescribed glucocorticoids that have been utilized for over two decades to increase muscular strength in DMD patients. Surgery may be necessary to address contractures, spinal curvature, or scoliosis, which can affect breathing and overall mobility. Additionally, interventions such as pacemakers or other cardiac devices may be utilized to improve heart function. Sarepta Therapeutics is a key player in the DMD market, boasting three approved assets and two in the current pipeline. Despite its dominance, emerging competition is evident. The historical success rate for market entry varies across the 7MM. Notably, the DMD market exhibits geographic disparities in regulatory approvals, with instances of products approved in one jurisdiction and rejected in another, despite identical clinical data, reflecting the distinct standards of regulatory bodies such as EMA and FDA. Learn more about the FDA-approved DMD drugs @ Drugs for Duchenne Muscular Dystrophy Treatment The current US DMD treatment market possesses approved products, EMFLAZA (deflazacort), VYONDYS 53 (golodirsen), EXONDYS 51 (eteplirsen), AMONDYS 45 (casimersen), and VILTEPSO (viltolarsen), ELEVIDYS (delandistrogene moxeparvovec) in patients with DMD. In January 2024, Santhera Pharmaceuticals announced the introduction of its AGAMREE (vamorolone) to treat DMD patients aged four years and above in Germany. Santhera Pharmaceuticals has officially entered the commercial stage of its biopharma journey with the launch of this drug in Germany. ELEVIDYS, the first FDA-approved gene therapy for DMD, received accelerated approval in June 2023. However, ICER recently challenged the potential conversion of Sarepta's gene therapy to full approval, citing concerns about the surrogate endpoint used in the approval process. In the EU4 and the UK, the current market is dominated by steroid therapies along with an approved medication targeting DMD patients with the nonsense mutation, TRANSLARNA (ataluren). In Japan, the only approved treatment is VILTEPSO (viltolarsen). ELEVIDYS is a prescription gene therapy designed for ambulatory children aged 4 to 5 years with DMD and a confirmed dystrophin gene mutation. It received accelerated approval. Patients will take oral corticosteroids before and after receiving ELEVIDYS and will have weekly blood tests to monitor liver enzyme levels for three months post-treatment. In June 2023, the USFDA approved ELEVIDYS as the first gene therapy for treating pediatric patients aged 4-5 years with Duchenne Muscular Dystrophy and a confirmed DMD gene mutation. VYONDYS 53, developed by Sarepta Therapeutics, is prescribed for treating DMD in patients with a specific mutation of the DMD gene that can be addressed by exon 53 skipping. This approval is under the accelerated approval pathway, based on the observed increase in dystrophin production in the skeletal muscle of patients treated with VYONDYS 53. The FDA approved VYONDYS 53 (golodirsen) in December 2019. Additionally, the FDA granted VYONDYS 53 (golodirsen) New Chemical Entity (NCE) exclusivity until December 2024 and Orphan Drug Exclusivity until December 2026. To know more about DMD treatment options, visit @ New Treatment for Duchenne Muscular Dystrophy The DMD market is crowded with so many companies including FibroGen, Santhera Pharmaceutical, Italfarmaco, ReveraGen BioPharma, Cumberland Pharmaceuticals, Sarepta Therapeutics, Antisense Therapeutics, Capricor Therapeutics, and others are running clinical trials to improve the treatment space. The DMD pipeline possesses potential drugs in mid-stage developments to be launched shortly. Some of the promising drugs in the pipeline include Pizuglanstat (TAS-205), SRP-5051, Allogeneic Cardiosphere-derived Cells (CAP-1002), ITF2357 (Givinostat), and others that hold the potential to create a significant positive shift in the DMD market size. Discover which therapies are expected to grab major DMD market share @ Duchenne Muscular Dystrophy Market Report Italfarmaco is developing Givinostat (ITF2357), an oral small molecule that functions as a histone deacetylase inhibitor with potential anti-inflammatory, anti-angiogenic, and antineoplastic properties. ITF2357 increases the production of follistatin protein in muscle cells by inhibiting the HDAC enzyme, leading to increased muscle mass and prevention of muscle degeneration. This action counters the effects of myostatin, helping to alleviate the symptoms of DMD. Givinostat is currently in Phase III trials. The FDA has granted it Orphan Drug, Rare Pediatric Disease, and Fast Track designations for DMD treatment. Additionally, the European Commission has designated Givinostat as an Orphan Medicinal Product for DMD treatment. TAS-205 (pizuglanstat) is a selective inhibitor of hematopoietic prostaglandin D synthase (HPGDS), developed by Taiho Pharmaceutical. It is being advanced as a treatment for Duchenne muscular dystrophy (DMD), effective irrespective of the type of dystrophin gene mutation. By inhibiting HPGDS, which worsens the inflammatory response in the muscles of DMD patients, it helps control the decline in motor function. Currently, it is in Phase III of clinical trials. Discover more about drugs for DMD in development @ Duchenne Muscular Dystrophy Clinical Trials The anticipated launch of these emerging therapies for Duchenne muscular dystrophy are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Duchenne muscular dystrophy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for DMD is expected to grow from USD 2.1 billion in 2023 with a significant CAGR by 2034. The growth of the DMD market is expected to be mainly driven by increased diagnosed incidence, patient awareness, and a robust clinical pipeline during the forecast period (2024–2034). DelveInsight's latest published market report titled as Duchenne Muscular Dystrophy Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the DMD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The DMD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Duchenne Muscular Dystrophy Age-specific Cases of Duchenne Muscular Dystrophy Ambulatory and Non-ambulatory Cases of Duchenne Muscular Dystrophy Mutation-specific Cases of Duchenne Muscular Dystrophy Associated Comorbidities in Duchenne Muscular Dystrophy The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM DMD market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this DMD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the DMD market. Also, stay abreast of the mitigating factors to improve your market position in the DMD therapeutic space. Related Reports Duchenne Muscular Dystrophy Epidemiology Forecast Duchenne Muscular Dystrophy Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted Duchenne muscular dystrophy epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Duchenne Muscular Dystrophy Pipeline Duchenne Muscular Dystrophy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Duchenne muscular dystrophy companies, including Santhera Pharmaceuticals, Sarepta Therapeutics, Italfarmaco, Wave Life Sciences Ltd, FibroGen, Edgewise Therapeutics, Pfizer, Daiichi Sankyo, Sarepta Therapeutics, Inc., ENCell, Taiho Pharmaceutical, Solid Biosciences, Capricor, Nippon Shinyaku, Hansa Biopharma, Ultragenyx Pharmaceutical, Dyne Therapeutics, Entrada Therapeutics, AAVogen, PepGen, Antisense Therapeutics, BioMarin Pharmaceutical, Avidity Biosciences, Sarepta Therapeutics, Dyne Therapeutics, Solid Biosciences Inc, Regenxbio, Stealth BioTherapeutics, among others. Nonsense Mutation Duchenne Muscular Dystrophy Pipeline Nonsense Mutation Duchenne Muscular Dystrophy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonsense mutation Duchenne muscular dystrophy companies, including Taiho Pharmaceutical, Solid Biosciences, Capricor, Nippon Shinyaku, among others. Becker Muscular Dystrophy Pipeline Becker Muscular Dystrophy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key becker muscular dystrophy companies, including Epirium Bio, Ultragenyx, Strykagen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Drug ApprovalOrphan DrugFast Track

14 Jun 2024

·www.drugs.com

FDA Approves Generic Emflaza Oral Suspension for Duchenne Muscular Dystrophy

FRIDAY, June 14, 2024 -- The U.S. Food and Drug Administration has approved the first generic version of Emflaza (deflazacort) oral suspension for Duchenne muscular dystrophy (DMD). Deflazacort oral suspension is a corticosteroid indicated to treat DMD in patients 5 years of age and older but is contraindicated in patients with known hypersensitivity to deflazacort. The most common adverse reactions reported in patients were Cushingoid appearance, weight increase, increase in appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis. "Duchenne muscular dystrophy is a devastating rare disease, and with limited treatment options available there is a critical need for the greater accessibility that a generic therapy can bring," Ketan Mehta, the founder and CEO of Tris Pharma, said in a statement. "This FDA approval is a significant milestone for the patients, caregivers, and physicians who may depend on this medication to treat DMD." Approval of the generic version of Emflaza oral suspension was granted to Cranbury Pharmaceuticals, a subsidiary of Tris Pharma. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug Approval

12 Jun 2024

·www.biospace.com

Cranbury Pharmaceuticals Receives U.S. FDA Approval for First Generic Version of Emflaza® Oral Suspension (deflazacort) for Duchenne Muscular Dystrophy

– Cranbury, a new subsidiary of Tris Pharma, will market more than 20 generic medicines and advance a diverse pipeline transitioned from Tris – – Deflazacort oral suspension is indicated to treat patients five years of age and older for Duchenne muscular dystrophy, a rare disease with limited treatment options available – – Immediate commercial availability of therapy underscores Cranbury’s commitment to providing patients with access to effective generic medicines across multiple disease states – MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)-- Cranbury Pharmaceuticals (Cranbury), a wholly-owned subsidiary of Tris Pharma, today announced the U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza® oral suspension (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD). The generic deflazacort oral suspension is now available to patients in the United States. This press release features multimedia. View the full release here: Deflazacort oral suspension is indicated to treat DMD in patients five years of age and older. DMD is a rare genetic disorder characterized by progressive muscle degeneration and weakness. The disease primarily affects boys, with symptom onset in early childhood. DMD occurs in approximately 1 in 5,000 live male births, and it is estimated that about 20,000 children are diagnosed with DMD globally each year.1 “Tris Pharma founded Cranbury as part of the company’s continued commitment to develop high-quality medicines and make them accessible to individuals who need them,” said Janet Penner, president at Cranbury Pharmaceuticals. “The launch of deflazacort oral suspension aligns with this commitment, and we are proud to provide this critical therapy to those with DMD. As a tenured member of the Tris team, I am honored to take on the role of president of our new subsidiary and have the opportunity to provide important generic medicines to patients with a range of disorders and diseases.” Tris founded Cranbury Pharmaceuticals with the vision to create high-quality, patient-friendly generic medicines that leverage Tris’ strengths in product selection, development and commercial launch. Cranbury will market more than 20 generic medicines and advance a diverse pipeline with the potential to address a range of disorders and diseases. The company will operate out of Tris’ headquarters in Monmouth Junction, New Jersey. “Duchenne muscular dystrophy is a devastating rare disease, and with limited treatment options available there is a critical need for the greater accessibility that a generic therapy can bring,” said Ketan Mehta, founder and CEO at Tris Pharma. “This FDA approval is a significant milestone for the patients, caregivers and physicians who may depend on this medication to treat DMD. Our portfolio of differentiated, high-quality generic medications has always been core to our business at Tris, and I look forward to continuing to expand our generic offerings under our new subsidiary, Cranbury Pharmaceuticals.” The spinout of Cranbury Pharmaceuticals follows Tris Pharma's recent launch of Tris Digital Health, a business focused on the development and commercialization of digital diagnostic and therapeutic products for neurological health conditions. The creation of these subsidiaries within Tris facilitates important progress and enables significant continued growth for the company’s digital health and generics portfolios. Tris Pharma will continue to focus on building its commercial portfolio of approved, best-in-class ADHD products and advancing its late-stage pipeline of innovative therapeutics in pain, ADHD, neurological disorders and addiction. INDICATION DEFLAZACORT oral suspension is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. IMPORTANT SAFETY INFORMATION Contraindications: DEFLAZACORT is contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients in deflazacort oral suspension. Warnings & Precautions Alterations in Endocrine Function: Corticosteroids, such as DEFLAZACORT, oral suspension, can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients receiving DEFLAZACORT oral suspension for Cushing’s syndrome, hyperglycemia, and adrenal insufficiency after deflazacort oral suspension withdrawal. In addition, patients with hypopituitarism, primary adrenal insufficiency, or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at increased risk for adverse endocrine events. Acute adrenal insufficiency or “withdrawal syndrome” can occur if corticosteroids are withdrawn abruptly and can be fatal. The risk is reduced by gradually tapering the corticosteroid dose when withdrawing treatment. During times of medical stress, corticosteroid dosage may need to be increased. Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal; Signs and symptoms of infection may be masked. Tell patients and/or caregivers to inform their healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Warn patients who are on corticosteroids who have not had chickenpox or measles to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed. Alterations in Cardiovascular/Renal Function: Corticosteroids, including DEFLAZACORT oral suspension, can cause elevation of blood pressure, salt, and water retention, and increased excretion of potassium and calcium. DEFLAZACORT oral suspension should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Monitor for elevated blood pressure. Dietary salt restriction and potassium supplementation may be needed. Gastrointestinal Perforation: Increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, and non-specific ulcerative colitis. Signs and symptoms may be masked. Avoid corticosteroids if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; or active or latent peptic ulcer. Behavioral and Mood Disturbances: Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including DEFLAZACORT oral suspension. Psychiatric adverse reactions usually involve hypomanic or manic symptoms (e.g., euphoria, insomnia, mood swings) during treatment and depressive episodes after discontinuation of treatment. Encourage patients to seek medical attention if symptoms develop or worsen. especially if depressed mood or suicidal ideation is suspected. Effects on Bones: Corticosteroids, including DEFLAZACORT oral suspension, decrease bone formation and increase bone resorption. The risk of osteoporosis increases with prolonged use of DEFLAZACORT, which can predispose patients to vertebral and long bone fractures. Consider a patient’s risk of osteoporosis before initiating corticosteroid therapy. Monitor bone mineral density in patients on long-term treatment with DEFLAZACORT, oral suspension. Ophthalmic Effects: May cause cataracts, infections, and glaucoma; Monitor intraocular pressure if DEFLAZACORT oral suspension is continued for more than 6 weeks. Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. Administer live attenuated or live vaccines at least 4 to 6 weeks prior to starting DEFLAZACORT oral suspension. Serious Skin Rashes: Toxic epidermal necrolysis has been reported with the use of deflazacort with symptoms beginning within 8 weeks of starting treatment. Discontinue at the first sign of rash, unless the rash is clearly not drug related. Effects on Growth and Development: Long-term use of corticosteroids, including DEFLAZACORT oral suspension, can have negative effects on growth and development in children. Thromboembolic Events: Observational studies have shown an increased risk of thromboembolism. Use DEFLAZACORT oral suspension with caution in patients who have or may be predisposed to thromboembolic disorders. Adverse Reactions: The most common adverse reactions (≥10% for DEFLAZACORT Oral suspension and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis. Drug Interactions: Give one third of the recommended dosage of DEFLAZACORT oral suspension. Avoid use of moderate or strong CYP3A4 inducers with deflazacort oral suspension, as they may reduce efficacy. To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or Please see Full Prescribing Information here. About Cranbury Pharmaceuticals Cranbury Pharmaceuticals is a subsidiary of Tris Pharma focused on the development and commercialization of high-quality, patient-friendly products that leverage the company’s strengths in product selection, development and commercial launch. Driven by patient-focused innovation, Cranbury will market more than 20 generic products and advance a diverse pipeline ready to transform new ideas into approved, effective medicines. Learn more at . About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is leveraging its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at and on LinkedIn @TrisPharma. References 1 Muscular Dystrophy Association. What is… Duchenne Muscular Dystrophy [Fact sheet]. .

Drug Approval

100 Deals associated with Deflazacort

External Link

KEGG	Wiki	ATC	Drug Bank
D03671	Deflazacort	H02AB13	DB11921

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Muscular Dystrophy, Duchenne	IT	-	01 Jan 1985

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Muscular Dystrophy, Limb-Girdle, Type 2I	Phase 3	US	PTC Therapeutics, Inc.	31 Oct 2019
Muscular Dystrophy, Limb-Girdle, Type 2I	Phase 3	CA	PTC Therapeutics, Inc.	31 Oct 2019
Muscular Dystrophy, Limb-Girdle, Type 2I	Phase 3	DK	PTC Therapeutics, Inc.	31 Oct 2019
Muscular Dystrophy, Limb-Girdle, Type 2I	Phase 3	FR	PTC Therapeutics, Inc.	31 Oct 2019
Muscular Dystrophy, Limb-Girdle, Type 2I	Phase 3	DE	PTC Therapeutics, Inc.	31 Oct 2019
Muscular Dystrophy, Limb-Girdle, Type 2I	Phase 3	NO	PTC Therapeutics, Inc.	31 Oct 2019
Muscular Dystrophy, Limb-Girdle, Type 2I	Phase 3	RU	PTC Therapeutics, Inc.	31 Oct 2019
Muscular Dystrophy, Limb-Girdle, Type 2I	Phase 3	SE	PTC Therapeutics, Inc.	31 Oct 2019
Kidney Diseases	Phase 1	US	PTC Therapeutics, Inc.	01 Dec 2014
Liver Diseases	Phase 1	US	PTC Therapeutics, Inc.	01 Dec 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01603407 (FOR-DMD, CTgov)	Phase 3	Muscular Dystrophy, Duchenne	196	Prednisone (Daily Prednisone)	ujaghymcuj(lbetqbqzpg) = iafazwsere qcwopzrlhe (gyfdaebybg, jpekbxqfwy - nobkwixywf) View more	-	12 Aug 2022
				Deflazacort (Daily Deflazacort)	ujaghymcuj(lbetqbqzpg) = jlkaisditx qcwopzrlhe (gyfdaebybg, kjvpbkrfnd - mcewqiowjd) View more
NCT03783923 (CTgov)	Phase 3	Muscular Dystrophy, Limb-Girdle, Type 2I	11	Deflazacort	zabhronhpc(gnzhdzvcpt) = xjmktzjdei oenposyoym (eqshgvhemh, obcxgcbiua - ivprghqlic) View more	-	27 Jun 2022
MDA2022	Not Applicable	Muscular Dystrophy, Duchenne	328	Deflazacort	loohxkfedf(ecklmkgozg) = adpsrlzlaa qwwazndzit (qkmhxilymw )	Positive	13 Mar 2022
PRO-DMD-01 and Cooperative International Neuromuscular Research Group (CINRG) (MDA2022)	Not Applicable	Muscular Dystrophy, Duchenne	463	Deflazacort	vhvzdwnsga(qoaqsdkdgx) = epdylomjum nzgnfltaye (liuacdczkp ) View more	Positive	13 Mar 2022
				Prednisone	fshydvfsjg(bedtrxftae) = daldkaxwza qvuskfaykz (lqjsschubq )
1847 (AAN2021)	Not Applicable	Muscular Dystrophy, Duchenne	97	Deflazacort 0.45mg/kg/day	bojpkuofku(pslhdbgvyn) = eazqqvxbfz owapsltzzz (broaosbvuv, 41.5)	Negative	13 Apr 2021
				Deflazacort 0.9mg/kg/day	bojpkuofku(pslhdbgvyn) = fccvnnnmwf owapsltzzz (broaosbvuv, 44)
4950 (AAN2020)	Not Applicable	Muscular Dystrophy, Duchenne	200	Deflazacort	gelefovukt(ztohsqpbwy) = vqgbkqhfza sqasmkzqpn (nyameiuuvy ) View more	Positive	14 Apr 2020
				Prednisone	czwvnvirtp(gylqzoxmho) = ouywlvqdiw nlvjowhnzw (gfxzabhnqu ) View more
AAN2019	Phase 3	Muscular Dystrophy, Duchenne	-	Deflazacort	ehcpptxaxe(epbcinruvd) = qlvrxawdld qdzeyvfcqn (ircwkmcobz, (0.5 - 4.1)) View more	Positive	09 Apr 2019
AAN2018	Not Applicable	Muscular Dystrophy, Duchenne	-	Deflazacort	hbuixkoqym(xceyeliruh) = ttwnreolwk poredyejyd (foctlrqgfb, 13.5)	-	10 Apr 2018
				Prednisone/Prednisolone	-
CNS2016	Phase 3	Muscular Dystrophy, Duchenne	196	Deflazacort 0.9 mg/kg/day	hadewniart(tsxzqdodft) = loivsqqicj njarrteuqi (augmsuymyr )	-	14 Oct 2016
				Deflazacort 1.2 mg/kg/day	kxzlepfjhz(bbbgvubyym) = pgdcxacrwz ujutqmtgyc (mhebyborkd )
P5.037 (AAN2016)	Phase 3	Muscular Dystrophy, Duchenne	196	Deflazacort 0.9 mg/kg/day	heledjpsov(zlbxfsbfzq) = fkyfysdcgt ikxuimkwjb (llgvggcfdm )	Positive	05 Apr 2016
				Deflazacort 1.2 mg/kg/day	qfhqnwgvvn(cavliqaaqv) = jdabhyzeub kqsvoxagxc (fnwaehshil )

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