US regulators have approved Schering-Plough’s Asmanex Twisthaler for the once-daily maintenance treatment of asthma as a preventive therapy in children.

The company noted that Asmanex (mometasone furoate) is the "first inhaled corticosteroid that is approved for once-daily dosing in children as young as four". The US Food and Drug Administration’s approval is based primarily on the results of a 12-week trial involving 296 patients aged four to 11 who had been diagnosed with asthma for at least six months.

The Asmanex Twisthaler uses an inhalation-driven device that does not use a propellant, S-P said, thus eliminating the need for hand-breath coordination. It also provides patients with a numeric dose counter that provides “a visual indication of the remaining doses”.

In 2005, the FDA approved Asmanex 220 mcg for patients 12 years and older and the new approval is for half that dose. Asmanex Twisthaler should be on the market in the second half of 2008.