In 1997, the Food and Drug Administration modernization act directed FDA to create a mechanism where important new drugs could get to patients more quickly. Under this act, drugs can be designated as “fast track” if they met two criteria: the drug must show promise in treating a life-threatening condition and the drug must address an unmet medical need.
Researchers are on the fast track to develop a drug to treat major depressive disorder in patients who don’t respond to standard therapies.
The company’s drug influences the opioid pathway, but in a non-addictive way and is designed to be taken once a day.
About 16 million people in the U.S. suffer from MDD in a given year, the majority of whom may not respond adequately to anti-depressant therapy.
Another potential breakthrough that has received fast track status is for a drug that could diminish gluten-induced intestinal injury in patients with celiac disease.
Currently, there are no approved therapies. Patients’ only option is to attempt to follow a strict, life-long gluten-free diet.
Celiac disease is the most common autoimmune disease, affecting more than two million people in the U.S.
The FDA receives approximately 100 to 130 applications a year, and has stated that close to 80 percent of all filed applications will eventually be approved.
Last year, only 22 drugs were accepted.