Key Points
- Veramyst, a nasal spray, clears the FDA
TIPS TO REMEMBER Veramyst - Veramyst must be primed before its first use.
- Remind patients to shake Veramyst well before each use.
- For best results, Veramyst should be used every day.
- Veramyst is approved for use in children as young as two years.
Just in time for the spring allergy season comes an intranasal steroid spray, fluticasone furoate (Veramyst, GlaxoSmithKline),
just approved by the Food & Drug Administration. Fluticasone furoate is a once-daily-dosed nasal spray indicated for the treatment
of seasonal and year-round allergy symptoms in adults and children two years of age and older.
"This will be a very welcome addition to our pharmacy shelves," said Jeffrey Burbank, BS.Pharm., a pharmacist for an independent
pharmacy in Brooklyn, N.Y., for the past 13 years. "Patients have been complaining about nasal sprays for some time. It's
about time a drug manufacturer listened to their grievances." Burbank went on to explain that patients have been asking why
the nasal sprays aren't made easier to operate. According to GlaxoSmithKline, fluticasone furoate will feature a side activation
button for more ergonomic handling and easier actuation.
Allergic rhinitis is one of the most prevalent and chronic diseases in the United States, affecting up to 30 million people,
including 10% to 30% of adults and up to 40% of children. Allergens, such as dust mites, animal dander, and pollen, can cause
inflammatory reactions in the nasal passages. This produces symptoms such as increased nasal discharge (runny nose), itching
and tearing eyes, and itching of the nose. These symptoms are cumulatively referred to as allergic rhinitis or nasal allergies.
Intranasal corticosteroid sprays are widely used to control the nasal symptoms, but until now have not been clinically proven
to reduce the itching eyes as well. "The idea of a steroid nasal spray also alleviating allergic eye symptoms is something
very interesting," Burbank said, adding that this could be a big selling point. 
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Another big issue with patients, Burbank said, was how to tell how much medicine is left in the bottle. "Patients are always
guessing how many doses they have left. They shake the bottle and try to remember how many doses they've used, but these methods
aren't very accurate." Fluticasone furoate will feature a window near the bottom, to show how much medicine is left. However,
Burbank does have a critique of the viewing window. "A dose counter would have been a better solution, as it would give the
patients an exact number of doses left."
Clinical trials of fluticasone furoate involved separate trials for adults and pediatrics. There were six adult trials, which
included 768 patients with seasonal or perennial allergic rhinitis. Three clinical pediatric trials included 795 children
with seasonal or perennial rhinitis. Side effects most often reported in the trials included epistaxis (nose bleeds) and nasal
ulcerations. In addition, there was a 52-week, placebo-controlled, long-term safety trial conducted. The trial population
consisted of 806 adult patients with perennial allergic rhinitis. Of the 605 patients receiving fluticasone furoate, 123 patients
(20%) reported epistaxis versus 17 patients (8%) in the placebo arm. No patient experienced a nasal septal perforation during
this trial.
According to packaging instructions, the pump must be primed before first use, if not used for 30 days, or if the cap has
been left off for more than five days. To prime, first shake the contents well and release six test sprays into the air away
from the face. Each spray (50 microliters) delivers 27.5 mcg of fluticasone furoate. Adult dosing is two sprays in each nostril
once daily. The dose may be titrated for individual patients; however, patients should be kept at the minimum effective dose
to minimize side effects. Once symptoms are controlled, the dose should be reduced to one spray in each nostril daily.
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