In the United States alone, more than 14 million Americans are diagnosed with COPD.1Â It is estimated that another 24 million people have evidence of impaired lung function, but are not yet diagnosed.2Â To date, supplemental oxygen, used for at least fifteen hours a day, is the only prescription drug that has been found to prolong survival in COPD.3Â These statistics alone are evidence that new medications are desperately needed to treat COPD more effectively and someday pave the way to a long-awaited cure.
Drug Development and Approval: A Tedious Process at Best
If youâ€™ve ever been taken aback by the cost of your prescription drugs, consider that, on average, it takes approximately 10 to 15 years and $1.2 billion for an experimental drug to make its way from the laboratory to a patient. Sadly enough, most drug compounds that enter the preclinical testing phase never make it to human testing. Of those that do make it, only 1 out of 5 is ever approved for sale.4
Once an aspiring drug compound is identified in the laboratory it must pass through the following developmental phases before itâ€™s actually approved by the FDA:4
- Preclinical testing â€“ during this phase the drug company conducts laboratory and animal studies to show that the drug is effective in treating the targeted disease.
- Investigational New Drug Application â€“ once preclinical testing is complete, the drug company files an application with the FDA to begin testing the drug in people.
- Clinical Trials, Phase I â€“ this phase involves testing the drug on 20 to 100 healthy human subjects and is, in part, designed to help drug companies determine a safe dosage range.
- Clinical Trials, Phase II â€“ this phase involves testing the drug on 100 to 500 volunteers who have the targeted disease and assesses the safety and efficacy of the drug in question as well as determines a drug side effect profile.
- Clinical Trials Phase III â€“ the final clinical phase of drug development usually involves treating 1000 to 5000 patients in various clinics and hospitals. Patients are closely monitored by physicians during this phase for effectiveness of the drug and adverse events.
- New Drug Application/Biologic License Application â€“ once clinical trials are complete, the drug company analyzes the data and files a new drug application or biologic license application showing the FDA that the data demonstrates the drug is both safe and effective.
- FDA approval â€“ once the FDA approves the new drug application or biologic license application, the new drug becomes available for doctors to prescribe.
The Latest Approved COPD Drugs
Although more are on the pipeline, only the following drugs have been approved by the FDA since 2011 for the treatment of COPD:
- Daliresp (roflumilast) â€“ Daliresp, a phosphodiesterase 4 (PDE4) inhibitor, helps block the bodyâ€™s production of PDE4, an enzyme thatâ€™s overproduced in COPD. It is the first drug of its kind to be approved (February 2011) for maintenance treatment of COPD. Developed by Forest Laboratories, Daliresp was shown in clinical studies to improve lung function and reduce COPD exacerbations in patients with moderate to severe forms of the disease.
- Arcapta Neohaler Â (indacaterol inhalation powder)â€” Developed by Novartis Â and approved by the FDA in July 2011, the Arcapta Neohaler is indicated for long-term bronchodilator treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.
- Tudorza Pressair (aclidinium bromide inhalation powder) â€“ A long-acting, inhaled muscarinic antagonist, the Tudorza Pressair was developed by Forest Laboratories and approved in July 2012 for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease.
- BREO ELLIPTA (fluticasone furoate/ vilanterol ) â€“ Approved by the FDA in May of 2013, the BREO ELLIPTA is a combination of an inhaled corticosteroid and a long-acting beta2 agonist (LABA). As a once-daily maintenance treatment, the combo inhaler helps prevent COPD exacerbations in patients who are prone to them.
For more information about new treatments for COPD and other chronic illnesses that are approved by the FDA, visitÂ Center Watch.
Author: Deborah Leader RN, BSN, PHN
1 Morbidity and Mortality 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases.
2 American Lung Association. COPD Fact Sheet. August, 2013.
3 American Lung Association. Oxygen Therapy Fact Sheet. 2013.
4 The Pharmaceutical Research and Manufacturers of America. Medicines in Development for COPD. January 12, 2012.