 |
|
|
The United States Food and Drug Administration approved Schering-Plough Corp's Asmanex Twisthaler for treatment of asthma in children aged between 4 and 11. Asmanex Twisthaler is a dry powder inhaler (DPI) which contains mometasone furoate. For children 4-11, the dosage is one 110 micrograms puff once a day. The drug was previously approved in 2005 for a 220 micrograms dosage in patients 12 years old and older.
"As the first inhaled corticosteroid that is approved for once-daily dosing in children as young as age four, the approval of the pediatric indication for Asmanex provides an important treatment option for children with moderate and mild persistent asthma," said Robert J. Spiegel, M.D., who is chief medical officer and senior vice president at the Schering-Plough Research Institute.
The FDA decision was based on results from a 12-week placebo-controlled trial of 296 patients 4 to 11 years of age who had been diagnosed with asthma for at least six months.
Mometasone furoate is a moderately potent glucocorticoid steroid more potent than hydrocortisone, and less potent than dexamethasone. Schering-Plough also sells the substance in nasal formulations as Nasonex and as a cream or ointment for skin conditions under the brand name Elocon or Elocom.
Asthma is a chronic condition in which the airway occasionally constricts, becomes inflamed, and is lined with excessive amounts of mucus. It has become a problem in urban environments in the developed world, where up to one in four children are suffering from this condition. It is known in the medical field at least since Hippocrates in 450 BC.
Its causes are not fully understood, but a variety of combined factors is suspected. It appears that certain environmental and genetic factors may only affect asthma when combined.
© 2007 - 2009 - eFluxMedia