New Allergic Rhinitis Treatment Avamys™ Approved In Europe
" Avamys is an effective new treatment for the 60 million Europeans whose working and home lives can be highly compromised by the symptoms of allergic rhinitis," stated Professor Wytske Fokkens, Chair of ENT Department, AMC, Amsterdam and Principal Investigator of the European Avamys phase III clinical trial. " Avamys has been shown in clinical trials to offer consistent and sustained relief from both the eye and nose symptoms associated with seasonal allergic rhinitis. These symptoms affect up to 70% of allergic rhinitis sufferers. For a disease where there is still high dissatisfaction with current therapies and a large amount of switching of medications, Avamys could prove to be a welcome arrival for affected patients."
This approval follows Positive Opinion from the European Medicines Agency granted in October 2007. Data presented to the European regulators included results from five randomised, double-blind, placebo-controlled phase III clinical trials involving 1,829 seasonal and perennial allergy patients 12 years of age and older.
The phase III studies show Avamys, a novel enhanced-affinity steroid, demonstrated superior efficacy to placebo in treating overall nasal allergy symptoms including congestion, sneezing, and itchy and runny nose in adults and children suffering from seasonal or year-round allergies. [1],[2],[3],[4] In addition, Avamys is the first intranasal corticosteroid spray consistently to demonstrate significant improvement in relieving overall eye symptoms associated with allergy such as red, itchy, burning and watery eyes in adult and adolescent patients with seasonal allergies.[5]
Avamys: a novel and patient-friendly device
The Avamys drug delivery device was designed and developed with patients in mind, in response to shortcomings in current nasal sprays identified by patients and physicians.[6],[7] The advanced, ergonomically designed Avamys device has a novel side-actuated button to make it easier to use by either the patient or their carer. The new device delivers a gentle and scent-free mist with a low volume of spray, which means patients are not left with a bitter taste or the effects of drip down the back of the throat. The device has a small nozzle, designed to increase comfort and fit more easily into the nose and a viewing window allows patients to see how much medicine is left in the device.
Avamys: improved quality of life
Symptoms resulting from allergic rhinitis can also have a significant impact on a patient's quality of life, including impairment of daily activities and interruption of sleep.[8] In one study, adult and adolescent patients with seasonal allergic rhinitis taking Avamys reported statistically significant and clinically meaningful improvements in overall allergy-related quality of life (QoL) scores compared with placebo. QoL measures included the impact of treatment for rhinitis on activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional problems.1,8
Avamys: favourable safety and tolerability profile
Patients who took Avamys in clinical trials reported adverse reactions with approximately the same frequency as those who received placebo. Common adverse reactions included headache, nose bleed and nasal sores seen in similar proportions as those reported for other intranasal steroids.1,3
The recommended starting dose is 110mcg (two sprays per nostril) once daily for patients 12 years of age and older. When symptoms have been controlled the dosage may be reduced to 55 mcg (one spray in each nostril once daily). The recommended starting dose is55mcg (one spray per nostril) once daily for children six to eleven years of age. Children not adequately responding to 55mcg may use 110mcg once daily. Once symptoms have been controlled, the dosage may be decreased to 55mcg once daily.
Avamys™ was first granted approval for use in the USby the FDA in April, 2007 under the trade name Veramyst™.
About allergic rhinitis
Allergic rhinitis, is an inflammatory reaction of the nasal passages to allergens, such as pollen, dust mites, animal dander, mould spores, and pollens. Within minutes of exposure to an allergen, immune response cells release chemicals such as histamine and leukotrienes that lead to inflammation and may produce symptoms including nasal congestion, sneezing and runny or itchy nose. Seasonal allergic rhinitis, which can also be known as hayfever, is triggered by pollens, occurs during certain seasons and lasts a few weeks to a few months. Perennial allergic rhinitis, triggered by dust mites, animal dander and mould, occurs year-round.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better, and live longer.
For company information visit http://www.gsk.com. To access Avamys media relations materials visit http://www.gsk.com/media.
References
[1] Fokkens WJ et al. Once daily fluticasone furoate nasal spray is effective in seasonal allergic rhinitis cased by grass pollen. Allergy 2007: 62: 1078-1084.
[2] Nathan R et al. Once daily Fluticasone Furoate Nasal Spray (FFNS), a Novel Enhanced Affinity Steroid, Provides 24-hour Relief for the Nasal symptoms of Perennial Allergic Rhinitis (PAR) Presented at the AAAI 2007. Data on file
[3] Kaiser H et al. Once-daily fluticasone furoate Nasal Spray (FFNS) is effective for the treatment of Seasonal Allergic Rhinitis (SAR) caused by Ragweed. Presented at the AAAI 2007. Data on file.
[4] Maspero J et al. Once-daily fluticasone furoate nasal spray is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. Abstract presented at AAAI 2007. Data on file.
[5] Derebery J. Enhanced-affinity Glucocorticoid Fluticasone Furoate Shows Consistent Efficacy against Ocular Symptoms of Seasonal Allergic Rhinitis (SAR). Presented at the meeting of the AmericanAcademyof Otolaryngic Allergy, 2007. Data on file.
[6] Meltzer E, Derebery J, Nathan R et al. Attributes related to nasal spray devices and formulation may contribute to stopping treatment with prescription intranasal sprays. AAAAI abstract 2007
[7] Berger W, Godfrey JW, Grant AC et al. Fluticasone furoate (FF) nasal spray - development of a next-generation delivery system for allergic rhinitis. Presented at AAAAI 2007
[8] Given J, Toler T, Ellsworth A, Stanford R, Philpot E. Once-Daily Fluticasone Furoate Nasal Spray 110mcg Improves Quality of Life (QoL) in Subjects with Seasonal Allergic Rhinitis (SAR) during the ragweed season. Presented at AAAAI 2007. Data on file.
View drug information on Veramyst.
New rinite alergice Tratamentul Avamys ? aprobat în Europa - New Allergic Rhinitis Treatment Avamys™ Approved In Europe - articole medicale engleza - startsanatate