SYMBICORT now available in the U.S. for asthma

Jun 26 2007

AstraZeneca has announced today that SYMBICORT (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler (pMDI) is now available in the United States for the long-term maintenance treatment of asthma in patients 12 years of age and older.

Administered twice daily, SYMBICORT is a combination of two proven asthma medications -- budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). For many patients, this combination treatment offers improved asthma control as early as day one that is sustained over 12 weeks. SYMBICORT also delivers improved lung function occurring within 15 minutes of beginning treatment. SYMBICORT does not replace fast-acting inhalers for sudden attacks.

SYMBICORT is available in two dose strengths, 80/4.5 and 160/4.5 5g of budesonide and formoterol, respectively. SYMBICORT is approved for patients whose disease is not adequately controlled on another asthma-controller medication (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.

"With the U.S. launch of SYMBICORT, millions of asthma sufferers will have a new choice of fixed combination therapy to help achieve control of their asthma," said Chris O'Brien, MD, PhD, senior director, Medical Science, AstraZeneca.

Asthma is one of the most serious chronic diseases in the U.S. It is estimated that more than 20 million Americans suffer from the condition and, if not properly managed, asthma can be life-threatening.

"The U.S. availability of SYMBICORT holds great promise for millions of Americans that suffer from asthma," said Tony Zook, president and chief executive officer, AstraZeneca U.S. "The addition of SYMBICORT to our respiratory portfolio reinforces AstraZeneca's commitment to developing new, effective treatments, and provides patients and physicians with a new treatment option to improve and maintain lung health."

SYMBICORT was approved by the U.S. Food and Drug Administration (FDA) on July 21, 2006. The SYMBICORT submission was based on 27 Phase I, II, and III trials designed to assess the efficacy and safety of SYMBICORT in a pMDI. The approved indication is largely based on data from two pivotal double blind, placebo-controlled, 12-week trials involving 1,076 patients in the U.S., age 12 and older. These studies showed that both dosage strengths of SYMBICORT produced a greater improvement in lung function compared to the same doses of budesonide or formoterol, administered alone, or placebo. In addition, these studies demonstrated a more rapid improvement in lung function compared to budesonide and placebo. Clinically significant improvement in bronchodilatory response, or opening of the lung airways, occurred within 15 minutes of beginning treatment with SYMBICORT.

The safety profile of SYMBICORT is based on a robust U.S. development program, which evaluated safety in over 6,000 patients treated with SYMBICORT in Phase I, II and III studies that were submitted to the FDA. SYMBICORT has safety data from long-term studies up to one year and a robust cardiac safety profile.

http://www.astrazeneca-us.com/