Daxas™ (roflumilast) approved in Canada for adult patients with severe
COPD - New option reduces flare-ups or "lung attacks"

OAKVILLE, ON, Dec. 14 /CNW/ - Nycomed Canada Inc. announced today that Daxas^™ (roflumilast), a first in a new class of treatment, is now approved in Canada as an add-on therapy to bronchodilator treatment for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent flare-ups.

Daxas^™ is the first approved phosphodiesterase 4 (PDE4) inhibitor. This treatment acts differently than bronchodilators which are first line treatment.  Daxas^™ is designed to treat the underlying COPD-related inflammation.ⁱ It does not directly impact everyday symptoms.ⁱⁱ A once daily tablet, Daxas^™ works in addition to current COPD bronchodilator treatments by improving lung functionⁱⁱ and reducing flare-ups.ⁱ  

In Canada, Daxas^™ is co-promoted by Nycomed and Merck and will be available in Canadian pharmacies in January 2011.

What is a flare-up or "lung attack"?
A flare-up or "lung attack", is a worsening of COPD symptoms, including cough, excessive inflammation, increase in shortness of breath and mucus production, and can result in hospitalization.^iii,iv It is a major cause of morbidity and mortality in the disease.ⁱⁱⁱ Despite the fact that studies have shown that patients admitted for a "lung attack" are more likely to die in the 12 months following hospital admission than patients admitted for a heart attack^v, some doctors and patients may underestimate their impact.^v,vi 

"Living with COPD, I understand how frightening and distressing a flare-up or lung attack can be. The coughing, breathlessness and the mucus can be so overpowering, that it feels like you are suffocating.  A really bad flare-up can land you in the hospital and the recovery can take a real toll on you and your body," says Hank Knol, who has lived with COPD for eight years and has been hospitalized eight times for a "lung attack".

The "Christmas Peak" and beyond
Respiratory infections, such as the common cold and the flu, appear to be the main trigger for a "lung attack".ⁱⁱⁱ "Lung attacks" are at their highest average annual levels during the Christmas period (also known as the "Christmas Peak"), because holiday social gatherings may be opportunistic for transmission of respiratory viruses.^iii,vii,viii

While COPD "lung attacks" are at their highest during the holiday season, a person with COPD continues to be at-risk, especially during the winter, since respiratory infections are more frequent.ⁱⁱⁱ  Prevention of "lung attacks" is therefore of fundamental importance for the well being of the COPD patient.^iii,vii

"COPD patients who suffer from chronic cough and sputum production, are at a higher risk of flare-ups or lung attacks," says Dr. Alan Kaplan, a family physician and the director of the Family Physicians Airways Group of Canada. "Roflumilast gives physicians a new option in reducing flare-ups which often plunge patients into a downward spiral, in terms of their lung function and quality of life."

Approval data
The efficacy and safety of Daxas^™ (roflumilast) was based on results from six Phase III trials. All trials were randomized, double-blind, placebo-controlled, parallel-group studies.  A total number of 7453 patients were randomized and treated (including 418 patients in Canada)^ix, of whom 3701 were treated with roflumilast.^x Two of the 12-month studies, published in The Lancet, demonstrated that roflumilast produced a statistically significant reduction in flare-ups, including patients who were also taking long-acting beta-agonists (LABAs).^i,x The pooled studies showed a reduction in moderate to severe flare-ups or "lung attacks" by 17 per cent per patient per year (rate of 1.14 events per year with roflumilast vs. 1.37 per year with placebo, p=0.0003).ⁱ Roflumilast incrementally decreased flare-ups (by 21 per cent) as compared to placebo in patients with concomitant treatment with long-acting beta-agonists (LABAs).ⁱ

Additional six-month studies provided further evidence that roflumilast significantly increases the lung function of COPD patients when added to long-acting bronchodilator therapy.ⁱⁱ

Diarrhea, weight loss, nausea, headache and abdominal pain were the most common adverse events recorded in patients in the trials. Overall, approximately 80 per cent of adverse events were mild to moderate in intensity and resolved on continued treatment.^x

"Treatment options which can improve lung function and reduce flare-ups may help these patients," says Henry Roberts, who is a member of the executive committee of COPD Canada, a patient association focused on providing education and support to people living with COPD. "While we welcome the approval of Daxas, reimbursement of this medication in a timely manner is what will be equally important, so that the patients who can benefit from it, many of whom tend to be elderly, can have access to it."

About COPD^xi
COPD is a respiratory disease that causes lung damage and airway obstruction (blocks the airways) and is sometimes called chronic bronchitis and/or emphysema.  COPD is primarily caused by smoking. It is the fourth leading cause of death in Canada, and research from the Lung Association shows that three million Canadians may have COPD. 

About Nycomed Canada Inc.
Nycomed Canada Inc. is the Canadian subsidiary of Nycomed GmbH; a European based, privately owned research-based company. Through its innovative products and dedicated people, Nycomed is committed to improving the health of Canadians. In Canada, Nycomed is active in the therapeutic areas of gastroenterology, respirology, and allergy. Headquartered in Oakville, Ontario, the company employs more than 130 people across the country. For more information, visit www.nycomed.ca.

^™ Trademark of Nycomed GmbH. Used under license.

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References
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ⁱ Calverley PMA, et al. Roflumilast treatment in symptomatic chronic obstructive pulmonary disease.  Lancet. 2009;374: 685-94.

ⁱⁱ Fabbri LM et al.  Roflumilast improves lung function in patients with moderately severe chronic obstructive pulmonary disease treated with long acting bronchodilators.  Lancet. 2009;374: 695-703.

ⁱⁱⁱ Taylor JD, Wreggett, KA, Olsson H et al. Latest therapies targeting exacerbations in COPD.  Drug Discovery Today:  Therapeutic Strategies (2008), doi: 10.1016/j.ddstr.2008.06.003

^iv The Lung Association, COPD Flare-Ups: What To Do Available at: http://www.lung.ca/diseases-maladies/copd-mpoc/flareups-pousseesactives/index_e.php#warning Accessed November 5, 2010.

^v Halpin, D. Mortality in COPD:  Inevitable or preventable? Insights from the cardiovascular arena.  COPD: Journal of Chronic Obstructive Pulmonary Disease. 2008;5(3): 187-200.

^vi Nycomed Hidden Depths of COPD Survey.  September 2010. Data on file.

^vii Johnston, NW. The similarities and differences of epidemic cycles of chronic obstructive pulmonary disease and asthma exacerbations. Proc Am Thorac Soc. 2007;4: 591-596.

^viii Johnston N, Hansell A, Childs A, et al.  (2007) Christmas as a risk factor for exacerbations of COPD, adult asthma and respiratory infections. Abstract retrieved from ERS database.

^ix Data on file.

^x Daxas [product monograph]. Oakville, ON:  Nycomed Canada; 2010.

^xi The Lung Association. COPD in Canada  Available at: http://www.lung.ca/_resources/COPD_in_Canada_CLA_2007.pdf  Accessed November 3, 2010.

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