Critical Therapeutics has launched its Zyflo (zileuton) in the USA, following the US Food and Drug Administration’s decision last month to allow the firm to manufacture and market the drug for the prevention and chronic treatment of asthma in patients 12 years of age and older. The product will be priced at a wholesale acquisition cost of $7.30 per day, or $219 per month.
Zyflo is the first and only drug in the class of 5-lipoxygenase inhibitors, which interrupt white blood cell activity contributing to the symptoms of asthma, to receive the green light from the FDA. It has been available in the USA since 1996, and the company acquired worldwide rights to the agent in 2003.
Paul Rubin, MD, president and chief executive officer of Critical Therapeutics, commented: “According to the American Lung Association, more than half of the estimated 20 million asthma patients in the USA do not have their asthma under control despite existing guidelines for the diagnosis and management of the disease. We believe Zyflo represents a safe and effective treatment option for some of these patients.”
The firm says it has built a specialty sales force that will target a group of approximately 8,000-10,000 allergy and respiratory specialists managing the majority of patients with the condition. “Through our 80-person specialty sales force, we believe we will initially have access to healthcare providers treating approximately 500,000 patients with severe persistent or difficult-to-treat asthma,” noted Rick Finnegan, senior vice president of sales and marketing.