Drug (Brand / Generic)
Flutiform / fluticasone proprionate and formoterol fumarate
Mundipharma and SkyePharma
Approved in Ireland, UK, Netherlands, Germany, Cyprus, Iceland, Denmark, Sweden, Norway, Austria, Slovakia, Poland, Bulgaria, Finland and the Czech Republic
Flutiform (fluticasone proprionate and formoterol fumarate) is a combination therapy used for the treatment of asthma. It is developed and manufactured by Mundipharma in association with SkyePharma.
The drug is developed by using SkyePharma’s SkyeDry formulation technology. It uses Landmark, a dose metering valve developed by Aptar Pharma.
In April 2012, Flutiform received positive opinion for the marketing approval in Europe, from the Committee for Medicinal Products for Human Use (CHMP).
Flutiform was approved for the treatment of asthma by the Irish Medicines Board, in November 2012.
The drug also received approval for treating asthma from the drug regulatory authorities across the UK, Netherlands, Germany, Cyprus, Iceland, Denmark, Sweden, Norway, Austria, Slovakia, Poland, Bulgaria, Finland and the Czech Republic.
Asthma – disease details, symptoms
Asthma is a common disease that causes inflammation of the bronchial tubes or airways that carry air to lungs. Common symptoms of the disease include wheezing, shortness of breath, coughing and chest tightness.
According to the World Health Organisation (WHO), around 235 million people in Europe are suffering from asthma. It has the highest prevalence in the UK.
The disease also has a large prevalence in Ireland. According to the Asthma Society of Ireland, one person a week dies due to asthma and more than 29% of the patients affected by asthma miss school.
Flutiform’s mechanism of action against asthma
Flutiform contains two combination ingredients, namely formoterol fumarate and fluticasone propionate. Fluticasone contains corticosteroids that help reduce swelling and inflammation in the airways. Formoterol contains bronchodilators, which make the inhale and exhale process easier by relaxing the narrowed airways.
Flutiform is available in aerosol inhalation form and can be administered in 250 / 10μg, 125 / 5μg, and 50 / 5μg doses.
Clinical trials on flutiform combination therapy
Mundipharma conducted a number of clinical trials on Flutiform to establish the efficacy and safety of the drug. The drug was submitted for the regulatory approvals in Europe and elsewhere based on eight Phase I / II studies and nine Phase III clinical studies.
The total number of patients enrolled for the clinical trials was more than 4,500, of which more than 1,900 patients received Flutiform. Two other medications, fluticasone / salmeterol and budesonide / formoterol, were also compared with Flutiform.
Mundipharma conducted two Phase III clinical trials on Flutiform to establish the efficacy, safety and tolerability in comparison with two other existing therapies for the treatment of asthma. The first Phase III study was a double-blind, parallel-group trial, which compared the efficacy and safety of Flutiform with the two current combination therapies.
The study enrolled 261 adult patients with moderate-to-severe, persistent reversible asthma. The second clinical study was an open-label, parallel-group, European multicentre study. It enrolled adult patients with asthma.
The studies were conducted for eight to 12 weeks. The results of the studies demonstrated that Flutiform was more effective in improving asthma symptom scores, as well as improving the lung function parameters when compared to the existing therapies.
The side effects found during the clinical study in Flutiform patients were similar to those of the two therapies compared in the studies.
Marketing Flutiform internationally
Dulera (Mometasone Furoate and Formoterol Fumarate Dihydrate) – Treatment for Asthma, United States of America
Dulera (mometasone furoate and formoterol fumarate dihydrate) is a new fixed-dose combination inhaler for the treatment of asthma. It was developed by Schering-Plough, which was merged with Merck in November 2009.
Flutiform has already been launched in the UK, Germany, The Netherlands and Cyprus. Mundipharma will hold the marketing rights of Flutiform in Europe and some other parts of the world; Kyorin Pharmaceutical will hold market rights in Japan; and Sanofi will hold the rights in Mexico, Central and South America.
Other medications available in the market for the treatment of asthma include Dulera and Singulair marketed by Merck, Advair developed by GlaxoSmithKline, and Symbicort produced by AstraZeneca.