Bufomix Easyhaler (budesonide/formoterol dry powder inhaler) / Orion Corp - LARVOL DELTA

The effect of lung emptying on the airway deposition of aerosol drugs (ERS 2023) - "Table 1. Relative change of the lung dose as a result of forceful breathe-out in comparison to no breathe-out Drug name Average relative change of lung dose (%) Significance of lung dose change at p=0.05 Onbrez Breezhaler -6.7 significant decrease Relvar Ellipta -1.4 insignificant decrease Seebri Breezhaler -1.1 insignificant decrease Bretaris Genuair 0.3 insignificant increase Foster NEXThaler 3.0 significant increase Bufomix Easyhaler 5.5 significant increase Symbicort Turbuhaler 9.6 significant increase; Respiratory intensive care; Epidemiology; Pulmonary function testing; Cell and molecular biology; General respiratory patient care; Public health"

Critical care

EASYRELIEF: Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing (clinicaltrials.gov) - P4 | N=180 | Completed | Sponsor: Orion Corporation, Orion Pharma | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

The effect of exhalation before the inhalation of dry powder aerosol drugs on the breathing parameters, emitted doses and aerosol size distributions. (PubMed, Int J Pharm X) - "The relative increase in the emitted dose varied between 0.2 and 8.0% (min: Foster® NEXThaler®, max: Bufomix® Easyhaler®), while the relative enhancement of fine particle dose ranged between 1.9 and 30.8% (min: Foster® NEXThaler®, max: Symbicort® Turbuhaler®), depending on the inhaler. All these effects and parameter values point toward higher airway doses due to forceful exhalation before the inhalation of the drug. At the same time, the present findings highlight the necessity of proper patient education on the importance of lung emptying, but also the importance of patient-specific inhaler-drug pair choice in the future."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

EASYRELIEF: Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing (clinicaltrials.gov) - P4 | N=180 | Recruiting | Sponsor: Orion Corporation, Orion Pharma | Trial completion date: Sep 2022 ➔ May 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

EASYRELIEF: Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing (clinicaltrials.gov) - P4 | N=180 | Recruiting | Sponsor: Orion Corporation, Orion Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

EASYRELIEF: Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing (clinicaltrials.gov) - P4; N=180; Not yet recruiting; Sponsor: Orion Corporation, Orion Pharma

Clinical • New P4 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

BufoSwitch: Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway (clinicaltrials.gov) - P=N/A; N=29; Terminated; Sponsor: Orion Corporation, Orion Pharma; N=1000 ➔ 29; Trial completion date: Dec 2021 ➔ Sep 2021; Recruiting ➔ Terminated; Trial primary completion date: Dec 2021 ➔ Sep 2021; Target recruitment not reached

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

BufoSwitch: Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway (clinicaltrials.gov) - P=N/A; N=1000; Recruiting; Sponsor: Orion Corporation, Orion Pharma; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Apr 2021 ➔ Dec 2021

Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Drugs at risk of export: Amantadine will no longer be monitored [Google translation] (rynekaptek.pl) - "Drugs removed from the anti-export list from July 2021: Airbufo Forspiro, Bufomix Easyhaler, Duoresp Spiromax and Symbicort Turbuhaler - a combination of anti-inflammatory budesonide and bronchodilator formoterol - were removed from the list. The monitoring will also not cover the Atimos inhalation aerosol (formoterol), the combination of beclometasone with formoterol under the name Fostex or the exceptionally long-lasting Oxis Turbuhaler with formoterol alone. The ternary drug Trimbow (beclomethasone, formoterol and glycopyrronium bromide) and the inhalation steroid Flixotide containing fluticasone are also disappearing from the list."

Reimbursement • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Ensuring therapeutic success through pharmaceutical concerns [Google translation] (Apotheke Adhoc) - "By changing the discount contract from June 2021, the topic can become relevant for the Bufori Easyhaler®: The Bufori Easyhaler ® is used for regular asthma therapy in adults and adolescents from 12 years of age and for the symptomatic treatment of chronic obstructive pulmonary disease (COPD) in adults....This currently includes the Easyhaler ®-Six product range in different dose strengths and pack sizes. Due to its wide range, the Easyhaler® is the only inhalation system that can be used or maintained in all stages of asthma and COPD therapy. Changing a well-trained inhalation system can compromise adherence and safe medication....In this case, the prescription must be provided with the special PZN 02567024 and a corresponding code as well as a handwritten explanation."

Commercial • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

BufoSwitch: Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway (clinicaltrials.gov) - P=N/A; N=1000; Recruiting; Sponsor: Orion Corporation, Orion Pharma; Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

BufoSwitch: Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway (clinicaltrials.gov) - P; N=1000; Not yet recruiting; Sponsor: Orion Corporation, Orion Pharma

New trial • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Budesonide and formoterol reduce early innate anti-viral immune responses in vitro (PLoS One) - Combination of budesonide and formoterol also inhibited RV16-stimulated expression of the type I IFN induced genes myxovirus protein A and 2,5' oligoadenylate synthetise; In RV16 stimulated PBMC, the combination of budesonide and formoterol inhibited IFNα and IP-10 production in asthmatic as well as healthy donors

In vitro study • Asthma

"Si el enfermo tiene flujos inspiratorios bajos funcionan mejor dispositivos de alta resistencia que dishomogenicen bien las partículas por ejemplo #easyhaler @OrionPharma @menarini_es o #handihaler @Boehringer Puede verse en la imagen de @J_AlejandroMD" (@drgonzalezmoro)

Sales of darolutamide started in the USA – Orion receives EUR 45 million milestone (GlobeNewswire, Orion Oyj) - Sales of darolutamide started in the USA – Orion receives EUR 45 million milestone. Sales of Nubeqa® (darolutamide), jointly developed by Orion Corporation and Bayer for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC), has started in the USA. The core therapy areas of Orion’s pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory diseases for which Orion develops inhaled Easyhaler® pulmonary drugs.

Clinical • Commercial • Regulatory