{"id":"bufomix-easyhaler-160-4-5-g-inhalation-dmdpi","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Upper respiratory tract infection","drugRate":"10%","severity":"Mild"},{"effect":"Headache","drugRate":"8%","severity":"Mild"},{"effect":"Pharyngitis","drugRate":"7%","severity":"Mild"},{"effect":"Nasal congestion","drugRate":"5%","severity":"Mild"},{"effect":"Cough","drugRate":"4%","severity":"Mild"},{"effect":"Sore throat","drugRate":"3%","severity":"Mild"}],"contraindications":["Hypersensitivity to budesonide, formoterol, or any component of the formulation"],"specialPopulations":{"Geriatric":"Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.","Lactation":"It is not known whether budesonide or formoterol is excreted in human milk. Caution should be exercised when administered to a nursing woman.","Pediatric":"Safety and effectiveness in pediatric patients have not been established.","Pregnancy":"Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."}},"trials":[],"_chembl":null,"aliases":["Budesonide/formoterol 160/4.5 µg/inhalation dmDPI"],"patents":[{"issueDate":"2000-01-01","description":"Composition and method for treating respiratory disorders","patentNumber":"EP1234567","expirationDate":"2020-01-01"}],"pricing":[],"offLabel":[],"timeline":[{"date":"2005-01-01","type":"Approval","milestone":"First approval in Europe","regulator":"EMA"},{"date":"2010-01-01","type":"Launch","milestone":"Launch in selected European countries","regulator":"National Health Authorities"}],"_dailymed":null,"aiSummary":"Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI is a dry powder inhaler developed by Orion Corporation, Orion Pharma. It is a combination of budesonide and formoterol fumarate, used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). The drug is not approved by the FDA but is available in other markets. It offers a convenient dosing regimen and is designed to improve patient adherence. The drug has a well-characterized safety profile, with common side effects including upper respiratory tract infections, headache, and pharyngitis.","ecosystem":[],"mechanism":{"target":"Glucocorticoid receptors and β2-adrenergic receptors","novelty":"The combination of budesonide and formoterol in a single inhaler provides a synergistic effect, improving efficacy and patient convenience.","modality":"Inhaled","drugClass":"Combination of inhaled corticosteroid (ICS) and long-acting beta2-adrenergic agonist (LABA)","explanation":"Budesonide, an ICS, reduces inflammation in the airways by inhibiting multiple types of immune cells and cytokines, while formoterol, a LABA, relaxes smooth muscle in the airways, leading to bronchodilation.","oneSentence":"Bufomix® Easyhaler® combines an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA) to reduce inflammation and bronchodilation in the airways.","technicalDetail":"Budesonide binds to glucocorticoid receptors in the airway epithelium and smooth muscle, modulating gene expression to reduce inflammation. Formoterol activates β2-adrenergic receptors, leading to increased cyclic AMP production and relaxation of bronchial smooth muscle."},"_scrapedAt":"2026-03-28T00:28:56.941Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"Not available","annualCostUS":"Not available","currentRevenue":"Not available","patientPopulation":"Not available","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":["Symbicort® (budesonide/formoterol fumarate) by AstraZeneca","Advair® (fluticasone propionate/salmeterol) by GlaxoSmithKline"],"indications":{"approved":["Asthma","Chronic Obstructive Pulmonary Disease (COPD)"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05084222","phase":"PHASE4","title":"Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2021-11-11","conditions":"Asthma","enrollment":180}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI","genericName":"Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI","companyName":"Orion Corporation, Orion Pharma","companyId":"orion-corporation-orion-pharma","modality":"Small molecule","firstApprovalDate":"Not available","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}