A brief look at some of the compounds in the pipeline for the treatment of asthma and COPD
The drug discovery and development process can take as long as 15 years and cost as much as $1 billion.
Applications for new drugs dropped from 160 in 2009 to 125 in early 2010; and only three drugs were approved for respiratory disease by the FDA in 2010, up from two in 2009.
Right now, there are more than 54,000 clinical trials in the United States alone. That means, given the number of applications in 2009 and 2010, only .2% of drugs now in clinical trials will ever make it to new drug application status. Clearly, for every successful drug launch, there are thousands of failures. Luckily for individuals with respiratory disease, the pharmaceutical industry continues to research new possibilities for breakthrough medicines. Below is a timeline to give you an idea of what takes place during each phase of drug discovery and development:
Prediscovery: To understand the disease and choose a target molecule by utilizing the basic research done by scientists in government, academic, and for-profit research institutions.
Discovery: Find a drug candidate by creating a new molecule or selecting an existing one, testing the molecule, and then changing its structure to make it work better.
Preclinical: Test drug to see if it is safe for human testing using laboratory animals.
Investigational New Drug: Obtain FDA approval for human testing.
Clinical Trials: Test for safety and effectiveness in humans. The candidate drug goes through three phases of human trials, starting with a small, healthy group and moving into larger groups of patients.
Review: FDA reviews results of all tests, including clinical and preclinical findings, and proposed labeling.
Manufacturing: Formulation and production of the new medicine.
Even after approval and manufacturing, drug companies continue to monitor the drug for unexpected serious side effects.
Now, let’s look at some drugs whose manufacturers hope will “make the cut.”
In the Pipeline for Treatment of Asthma and COPD is available as a downloadable pdf – you will need Adobe Acrobat reader to view this.
If you do not have Adobe Acrobat on your computer, you can download it for free from Adobe.com.