GlaxoSmithKline plc announced that once-daily Avamys (fluticasone furoate) nasal spray has received a positive opinion from the European Medicines Agency (EMEA) for the treatment of the symptoms of allergic rhinitis in adults, adolescents (12 years and over) and children (6-11 years).
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. In addition, Avamys is the first intranasal corticosteroid spray to demonstrate consistently 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.
"Today's positive opinion for Avamys is important for the 60 million Europeans whose quality of life is seriously impacted by allergic Rhinitis. Up to 70 per cent of people with allergic rhinitis suffer from symptoms that affect both the nose and the eyes and Avamys is the only prescription nasal steroid spray that has demonstrated consistent efficacy within clinical studies, in relieving both these symptoms associated with an allergic response. Importantly this relief from the main symptoms of allergic rhinitis has been shown to be sustained for over 24 hours," said, Andrew Witty, president, GSK Pharmaceuticals, Europe and CEO designate.
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. The advanced, ergonomically designed Avamys device has a unique 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.
"How well a medicine performs depends not only on having a very effective therapy, but also on the performance of the delivery device. The design team at GSK worked hard to understand fully the concerns and needs of patients, and has produced a device that should be more comfortable and easy to use than previous nasal sprays. By addressing the importance of the design of the nasal spray, as well as developing an effective medicine, Avamys has the potential to not only improve symptom relief, but also improve patient compliance," said Darrell Baker, senior vice president, Respiratory Medicines Development Centre.
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. In a 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 on activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional problems.
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, nosebleed and nasal sores seen in proportions expected for other intranasal steroids.
The recommended starting dose is 110 mcg (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 is 55 mcg (one spray per nostril) once daily for children six to eleven years of age. Children not adequately responding to 55 mcg may use 110 mcg once daily. Once symptoms have been controlled, dosage reduction to 55mcg once daily is recommended.
Avamys was first granted approval for use in the US by the FDA in April 2007 under the trade name Veramyst.
Allergic rhinitis, commonly known as hay fever, is an inflammatory reaction of the nasal passages to allergens, such as 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, 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 mold, occurs year-round.