GlaxoSmithKline has been boosted by the news that European regulators have given the green light to the firm’s hay fever treatment Avamys.
The European Commission has granted marketing authorisation for Avamys (fluticasone furoate), a once-daily nasal spray for the treatment of the symptoms of allergic rhinitis. The approval is based on data that includes results from five Phase III clinical trials involving just over 1,800 seasonal and perennial allergy patients.
GSK noted that Avamys is the first intranasal corticosteroid spray “consistently to demonstrate significant improvement in relieving overall symptoms associated with allergy such as red, itchy, burning and watery eyes”. The company also touted the “advanced, ergonomically-designed device” it has developed “in response to shortcomings in current nasal sprays”.
The Avamys device has a side-actuated button to make it easier to use and delivers what GSK describes as “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. It 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.
The drug, under the brand name Veramyst, was approved by US regulators in April 2007 and analysts believe that it could become a $1 billion product.
Positive data from RLS trial
Meantime, GSK and partner XenoPort have reported positive results from a second late-stage trial of XP13512, a gabapentin prodrug, in patients with moderate-to-severe primary restless legs syndrome.
The Phase III 24-week study, a follow-on from an earlier 12-week trial, involved 327 patients with RLS. It showed that treatment with XP13512 resulted in a lower proportion of relapses than placebo during the double-blind nine-month treatment period (23% versus 9%). The drug was generally well-tolerated.
Up to 12 million people in the USA are though to suffer with RLS, which is characterised by unpleasant and sometimes painful sensations in the legs that result in a compelling urge to move. Because symptoms typically occur at night, RLS patients often suffer from sleep disruption.
The deal with GSK was signed last February and in December 2005, XenoPort licensed Astellas the rights to develop and commercialise XP13512 in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. GSK noted that it expects to file for US approval in the third quarter.
