Fast Track: Major Depressive Disorder Drug - NewsChannel5.com | Nashville News, Weather & Sports

Fast Track: Major Depressive Disorder Drug

Posted: Updated:

ORLANDO, Fla. (Ivanhoe Newswire) - In 1997, the Food and Drug Administration Modernization Act directed the 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.

RESEARCH SUMMARY

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:http://www.nimh.nih.gov/health/topics/depression/index.shtml andhttp://www.webmd.com/depression/guide/major-depression)

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: http://www.news-medical.net/news/20131010/Alkermes-ALKS-5461-drug-gets-FDA-Fast-Track-status-for-major-depressive-disorder.aspx and http://www.fiercebiotech.com/press-releases/alkermes-announces-positive-results-clinical-study-alks-5461-major-depressi)           

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:http://www.mayoclinic.com/health/celiac-disease/DS00319)

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:http://www.alvinepharma.com/press-sept0512/)

  • Medical News HeadlinesMedical News HeadlinesMore>>

  • Migraine Relief: Stopping Pain & Relieving Pressure

    Migraine Relief: Stopping Pain & Relieving Pressure

    Friday, April 18 2014 5:15 PM EDT2014-04-18 21:15:06 GMT
    Meredith Messerli is thankful she can study without pain. The college freshman spent two years of her life battling severe migraines.more>>
    Meredith Messerli is thankful she can study without pain. The college freshman spent two years of her life battling severe migraines.more>>
  • Hope For Lanie: Curing SMA

    Hope For Lanie: Curing SMA

    Thursday, April 17 2014 5:15 PM EDT2014-04-17 21:15:09 GMT
    SMA attacks the body's motor neurons and causes paralysis. There is no cure, but for the first time doctors are studying an experimental therapy that targets more than just symptoms.more>>
    SMA attacks the body's motor neurons and causes paralysis. There is no cure for SMA but for the first time doctors are studying an experimental therapy that targets more than just symptoms, it targets mutated SMN genes, which are responsible for SMA.more>>
  • Washing Lungs & Breathing Better

    Washing Lungs & Breathing Better

    Wednesday, April 16 2014 5:15 PM EDT2014-04-16 21:15:09 GMT
    Imagine not being able to breathe without struggling: every breath you take is work; every breath you take could be your last. That was the case for one man who became dependent on an oxygen tank to stay alive.more>>
    Imagine not being able to breathe without struggling: every breath you take is work; every breath you take could be your last. That was the case for one man who became dependent on an oxygen tank to stay alive.more>>
  • Ocular Melanoma: Saving Lives, Saving Eyes

    Ocular Melanoma: Saving Lives, Saving Eyes

    Friday, April 11 2014 5:15 PM EDT2014-04-11 21:15:07 GMT
    Ocular melanoma, also called uveal melanoma, is a rare type of melanoma that targets the eye. It can be a deadly if it isn't spotted early enough. Now, there's a way to treat patients that's saving lives and saving eyes.more>>
    Ocular melanoma, also called uveal melanoma, is a type of melanoma that targets the eye. It affects about 2,000 people a year in the United States. Although rare – it can be a deadly if it isn't spotted early enough. Now, there's a way to treat patients that's saving lives and saving eyes.more>>
  • Memory Palace: Coping With Chemo Brain

    Memory Palace: Coping With Chemo Brain

    Thursday, April 10 2014 5:15 PM EDT2014-04-10 21:15:09 GMT
    More than 13 million Americans are living with some form of cancer. Harsh treatments like chemo and radiation save lives, but they will also change lives. Now, many cancer survivors are learning how to cope with chemo brain.more>>
    More than 13 million Americans are living with some form of cancer. Harsh treatments like chemo and radiation save lives, but they will also change lives. Now, many cancer survivors are learning how to cope with chemo brain.more>>
  • Pedaling For A Cure

    Pedaling For A Cure

    Wednesday, April 9 2014 5:15 PM EDT2014-04-09 21:15:09 GMT
    Five years ago, Leslie Trudeau's world came crashing down. At just 22 years old, her son Taylor lost his battle with leukemia. That's why Trudeau is pedaling for a cure.more>>
    Five years ago, Leslie Trudeau's world came crashing down. At just 22 years old, her son Taylor lost his battle with leukemia. That's why Trudeau is pedaling for a cure.more>>
  • Bringing Hearts Back To Life: New Improved Defibrillator

    Bringing Hearts Back To Life: New Improved Defibrillator

    Tuesday, April 8 2014 5:15 PM EDT2014-04-08 21:15:13 GMT
    CPR and a portable defibrillator helped keep Eric Robinson alive after he went into cardiac arrest. And now a newly FDA approved Biotronik implantable cardiac defibrillator, or ICD, constantly monitors his heart.more>>
    A year ago, while jamming with his son's band, Eric Robinson went into cardiac arrest. CPR and a portable defibrillator helped keep Robinson alive. And now a newly FDA approved Biotronik implantable cardiac defibrillator, or ICD, constantly monitors his heart.more>>
  • Helping High Risk Hearts

    Helping High Risk Hearts

    Monday, April 7 2014 5:15 PM EDT2014-04-07 21:15:09 GMT
    Ironing is not exactly Barbara Roy's favorite activity, but it's something she's glad she can do again. Her doctor diagnosed her with severe aortic stenosis.more>>
    Ironing is not exactly Barbara Roy's favorite activity, but it's something she's glad she can do again. Her doctor diagnosed her with severe aortic stenosis.more>>
  • Hernias In Newborns: Lincoln's Story

    Hernias In Newborns: Lincoln's Story

    Friday, April 4 2014 5:15 PM EDT2014-04-04 21:15:07 GMT
    Congenital diaphragmatic hernias occur in about one in every 2,000 births. They can be deadly, but now doctors are using a more aggressive treatment approach.more>>
    Congenital diaphragmatic hernias occur in about one in every 2,000 births. They can be deadly, but now doctors are using a more aggressive treatment approach.more>>
  • Predicting Bad Hearts

    Predicting Bad Hearts

    Thursday, April 3 2014 5:15 PM EDT2014-04-03 21:15:09 GMT
    Every year, more than 700,000 Americans have a heart attack. Now, researchers at Baylor Research Institute at Dallas have uncovered a biomarker that may help them spot the disease sooner.more>>
    Every year, more than 700,000 Americans have a heart attack. And 600,000 die of heart disease. Now, researchers at Baylor Research Institute at Dallas have uncovered a biomarker that may help them spot the disease sooner; and they did it by pure accident.more>>
Powered by WorldNow
Powered by WorldNow
All content © Copyright 2000 - 2014 NewsChannel 5 (WTVF-TV) and WorldNow. All Rights Reserved.
For more information on this site, please read our Privacy Policy and Terms of Service.