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Articles
Example medicines to prescribe by brand name in primary care
27 March 2022Prescribe certain medicines by brand to ensure supply of the same product. Examples are grouped by therapeutic area. The list of products is not exhaustive.
Ethanol content of inhalers – What is the significance?
13 December 2019Ethanol is included as an excipient in many commonly prescribed inhalers, including some licensed for use in children. Patients may have ethical, religious or cultural…
New Medicines
SymbicortAsthma in adults and adolescents where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate - 100/3 MDI formulation
Information
Symbicort
New formulation
AstraZeneca
AstraZeneca
Development and Regulatory status
Launched
None
None
November 2020
Nov 20Symbicort 100/3 MDI available in UK and costs £14 per 120 dose inhaler [2].
Jun 20MHRA approves Symbicort 100 micrograms/3 micrograms/actuation pressurised inhalation for use in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists, or in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists [1].
Category
LABA plus inhaled corticosteroid. Each actuation delivers: budesonide 80 micrograms and formoterol fumarate dihydrate 2.25 micrograms (delivered, ex-actuator). This is equivalent to budesonide 100 micrograms and formoterol fumarate dihydrate 3 micrograms.
In the UK, 4.3 million adults receive treatment for asthma (~6,500 per 100,000 people). In 2013, ~65% of patients on at least an ICS/ LABA were uncontrolled.
Asthma in adults and adolescents where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate - 100/3 MDI formulation
Inhalation
DuoResp Spiromax Asthma in adolescents aged 12 years and older
Information
DuoResp Spiromax
Licence extension / variation
Teva
Teva
Development and Regulatory status
Launched
Launched
None
November 2021
Nov 21MHRA approves licence extension for DuoResp Spiromax. The new indication is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists or in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists [4].
May 21Licence extension approved in EU [3].
Apr 21EU positive opinion for a change to an extension to the existing indication to include use in adolescents from the age of 12 years. The proposed new indication is use in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists or in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. Also DuoResp is already licensed for use in adults for the symptomatic treatment of COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators [2].
Category
Corticosteroid and rapid-acting and long-lasting beta-2 agonist, in a dry powder inhaler.
5.4 million people in the UK receive treatment for asthma: 1 in 11 children and 1 in 12 adults. It is the most common chronic medical condition in children [1].
Asthma in adolescents aged 12 years and older
Inhalation
Evidence based evaluations
Symbicort TurbohalerMild asthma - as needed in adults and adolescents
Information
Symbicort Turbohaler
Licence extension / variation
AstraZeneca
AstraZeneca
Development and Regulatory status
Phase III Clinical Trials
Filing withdrawn
Pre-registration (Filed)
Feb 22Company is still planning to seek a licence for mild asthma in the UK [14].
Jul 21AstraZeneca have withdrawn the EU filing for Symbicort Turbohaler as an anti-inflammatory reliever in mild asthma due to a negative assessment from the Swedish Medical Products Agency (MPA) [13].
Nov 20Has been filed in the EU, with a decision expected H1 21 [12].
Sep 20EU filings now planned for H2 20 [11].
Mar 20Currently pre-registration in US [10].
Dec 19No longer listed as filed in company pipeline. Planned filings in the EU based on SYGMA are now H1 20 [8].
Dec 18EU filing submission accepted [7].
May 18EU filing will be using centralised procedure [6].
Dec 16EU filing still planned for 2018 [3].
Dec 14PIII SYGMA studies start; EU filing planned for 2018 [1].
Category
LABA plus inhaled corticosteroid.
5.4 million people in the UK receive treatment for asthma: 1 in 10 children and 1 in 12 adults.
Mild asthma - as needed in adults and adolescents
Inhalation
Trial or other data
Dec 17PIII SYGMA1 and 2 meet their primary outcomes [5].
Dec 16PIII SYGMA1 and 2 data expected H2 2017 [4].
Nov 14PIII SYGMA2 (NCT02224157) study starts. The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used ´as needed´ in patients with milder asthma. The efficacy of Symbicort ´as needed´ will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler ´as needed´. 4,114 patients aged 12 years and older will be recruited sites globally. Primary outcome is a annual severe asthma exacerbation rate; collection of these data should complete Aug 17 [2].
Jul 14PIII SYGMA1 (NCT02149199) study starts. The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbohaler® is effective in treating asthma when used ´as needed´ in patients with milder asthma. The efficacy of Symbicort® ´as needed´ will be compared with: 1) terbutaline Turbuhaler® ´as needed´ and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® ´as needed´. 3,750 patients aged 12 years and older will be recruited from Argentina, Chile, China, Brazil, South Africa, Philippines, Peru, Hungary, Mexico, Russia, Bulgaria, Korea, United Kingdom, Australia, Canada, Poland, Ukraine, Romania and Vietnam. Primary outcome is a Well-controlled asthma week´ - a derived binary variable; collection of these data should complete Aug 17 [2].