Vol. 21 •Issue 4 • Page 17
FDA Approves New Drug for Asthma Control
The Food and Drug Administration last month approved a new asthma inhalation aerosol drug for sale in the U.S. The drug, Alvesco® (ciclesonide) was designed for the maintenance and prophylactic treatment of asthma in patients 12 years of age and older.
The new drug, by Nycomed, is an inhaled corticosteroid with novel release and distribution properties, according to company officials.
At the current time, Nycomed is in active negotiations with possible marketing partners for commercialization of the drug in the U.S.
“The approval of Alvesco provides a new and effective treatment option to help patients control their asthma and improve their quality of life,” said Myron Zitt, MD, chief of allergy and immunology at the Queens Long Island Medical Group in Babylon, N.Y.” It will be an important treatment for options.”
Results of Phase III clinical research on Alvesco were published in the December 2005 issue of the Journal of Allergy and Clinical Immunology and researchers at that time reported the drug to be effective and safe.
The most common adverse reactions, seen in fewer than 1 percent of cases, were mild to moderate in severity and included headache, oral candidiasis, pharynogolaryngeal pain and cough. Other possible side effects included dry mouth, nausea, chest discomfort and immediate or delayed hypersensitivity reactions such as angiodema with swelling of the lips, tongue and pharynx.
Most common side effects, seen in fewer than 3 percent of users, were headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, athralgia, nasal congestion, pain in extremity and back pain.
Full benefits of the drug may not be achieved until treatment has been administered for up to four weeks.
Nycomed is a Swiss company headquartered in Zurich.