See What is Racing Down the FDA Fast Track

See What is Racing Down the FDA Fast Track

Find out what is now racing down the FDA fast track to approval.

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.

MAJOR DEPRESSIVE DISORDER: Major depressive disorder (MDD) or clinical depression is a type of depression that physically affects a person’s ability to eat, sleep, work, study, etc. Those who suffer from the condition are not able to enjoy their favorite activities due to the overwhelming feelings of depression and sadness. Major depressive disorder prohibits patients from daily normal functions and begins to take over their life and well-being. Symptoms of major depression disorder can include: a constant loss of energy, insomnia or hypersomnia, thoughts of death or suicide, and feeling worthless. (Source: and
TREATMENT: A new drug, ALKS 5461, has recently been Fast Tracked by the FDA to treat patients with major depressive disorder. Alkermes plc designed ALKS 5461 to help patients who are not responding to standard therapies. This is a non-addictive opiate that is also being tested for the treatment of cocaine addiction. (Source: and          
CELIAC DISEASE: Celiac disease is a reaction to eating gluten found in rye, wheat, and barley. Over time, if a person with celiac disease continues to consume gluten-enriched foods, it can damage the lining of the small intestine and cause malabsorption. This will start to affect the bones, nervous system, brain, liver and other organs. There is no cure for celiac disease, but eating a gluten-free diet will help in managing symptoms. (Source:
MEDICATION: Alvine Pharmaceuticals, Inc. recently released a new drug, ALV003 to be Fast Tracked by the FDA. This new medication is designed to treat the needs of celiac disease patients in partnership with a gluten-free diet. There are no forms of treatment or therapy on the market to treat Celiac disease, ALV003 is the first. (Source:

MDD Drug:
Alkermes plc

Celiac Disease Drug:
Alvine Pharmaceuticals, Inc.
(650) 632-1645

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