New Psychiatric Medications in the Pipeline

About 300 medicines in the research and development pipeline are aimed at treating mental illnesses.
About 300 medicines in the research and development pipeline are aimed at treating mental illnesses.

The Research and Development Pipeline

Almost 60 million American adults and 300 million people worldwide suffer from some form of mental illness. In the past fifty years we have learned a great deal about mental illness and have seen phenomenal breakthroughs in treatments for mental illness. People who would have been disabled and institutionalized fifty years ago are now able to function in their communities and maintain their independence.

Researching and developing new medicines to treat mental illness is a slow and expensive process. There are about 3,000 medicines of all kinds in some stage of development, from early research to later trials to awaiting approval by the FDA. About 300 medicines in the research and development pipeline are aimed at treating mental illnesses.

Medicines in Development for Mental Illness

Disorder
# Drugs in Pipeline
# US population impacted
Depression and mood disorders
71
21 million
Addictive disorders
33
25 million**
Anxiety disorders
38
40 million
Dementias (including Alzheimer's)
90
5 million
Schizophrenia
54
2.4 million
Attention Deficit/Hyperactivity disorder
20
1 in every 20 children
Developmental disorders (includes autism)
6
1 in every 110 8 year olds
Eating disorders
33
***
Personality disorders
2
not available
Premenstrual disorders
2
up to 75% PMS, 5% PMDD
Sleep disorders
21
not available
Other
3
****
*Some medicines are in development for more than one disorder.

**Alcoholism afflicts 13 million adults and children. 12.5 million Americans are addicted to other drugs. Another 40 million family members, children and victims of drunk drivers are affected indirectly.

*** 0.6% of adult population in the US suffers from anorexia, 1.0% from bulimia, and 2.8 percent from a binge eating disorder. 32.7% overweight, 34.3% obese, 5.9% extremely obese.

****Schizoaffective disorder 0.2% to 0.5% - a combination of symptoms of schizophrenia and mood disorder

Examples of Medications Now Being Tested to Treat Mental Illness

Schizophrenia

  • A medicine to treat both positive and negative symptoms of schizophrenia without the negative side effects that are common with current antipsychotic medications.

Schizophrenia is the most common type of psychotic disorder, and is very disabling. A person with a psychotic disorder loses touch with reality. In addition to psychotic symptoms of hallucinations and delusions, a person with schizophrenia experiences disturbances in thinking, emotional reactions and behaviors.

Alzheimer's Disease

  • A medicine to treat Alzheimer’s disease that removes beta amyloid protein from the brain that will prevent or reverse progression of Alzheimer’s.

Early signs of Alzheimer’s include a decreased attention span, poor concentration, personality change and forgetfulness. As the disease progresses there is a loss of computational ability, problems with finding words, and difficulty with ordinary activities.In later stages, there is severe memory loss, complete disorientation, social withdrawal, loss of independence, and finally death. Alzheimer’s is the seventh leading cause of death in the US.

Three years after Alzheimer’s disease begins, half of untreated patients are placed in nursing homes, compared with only 11% of patients who receive treatment. One study found that if a new treatment is found that can delay the onset of Alzheimer’s, Medicare and Medicaid spending on patients with Alzheimer’s would be reduced by more than $100 billion a year by 2030. If no new medicines are found, Alzheimer’s disease could affect 13.5 million Americans by 2050.

The Drug Development and Approval Process

The US system for new drug approvals is the most rigorous in the world. On average, it takes 10-15 years and $1.3 billion to get a drug from the laboratory to a patient. The process involves the following steps.

Preclinical Testing

The drug company demonstrates through lab and animal studies that the compound targets disease and is safe.

Investigational New Drug Application (IND)

After preclinical testing, the company files an IND with the FDA (Food and Drug Administration) to begin to test the drug on people. The IND shows results of previous experiments and provides information about the compound and how it works in the body, the proposed studies, and findings from the animal studies. Annual progress reports are submitted to FDA.

Clinical Trials – Phase I

Tests involve 20-100 normal, healthy individuals. The studies determine how a drug acts in the body and how long the effects of the drug last.

Clinical Trials, Phase II

This phase involves drug trials with 100 to 500 patients with the disease the drug is intended to target. The effectiveness of the drug is studied as well as any early side effects.

Clinical Trials, Phase III

Phase III involves 1,000 to 5,000 patients. Doctors monitor patients in clinics and hospitals to see if the drug is working and to identify any adverse effects.

New Drug Application (NDA)/Biologic License Application (BLA)

When the clinical trials are completed, the company analyzes the data from the trials. If the data supports that the drug is effective and safe, the company files an NDA or BLA with the FDA. The application includes all of the data and scientific information the company has gathered. The applications are typically 100,000 pages or more and take about 13 months to review. There were 25 new drugs approved in 2009. The average review time was 13.3 months.

Approval

Once approved, the new medicine becomes available, and physicians begin to prescribe them to patients. The company continues to send reports to the FDA, including reports on any adverse reactions to the drug. For some medicines, FDA requires additional trials (Phase IV) to evaluate long-term effects of the medicine.

Other Drugs in the Development Pipeline for Mental Illness

Anxiety (Social Phobia) – One medicine in the pipeline for anxiety is part of new class of psychotropic pherines. The drug is administered in an intranasal spray. It acts very rapidly on nasal chemosensory neurons that act on the hypothalamic-limbic system in the brain. The clinical trials demonstrated that it improved social performance and social interaction anxiety within 10 minutes of administration.

ADHD – A new medicine in the developmental pipeline targets specific receptors (NNRs), which release several neurotransmitters and control the flow of neuron signaling. In clinical trials it demonstrated improvement in ADHD symptoms, improved academic and occupational functioning, and improved quality of life.

Cocaine Addiction – Currently there is no medication treatment for cocaine addiction. A vaccine is in development that might be an effective treatment. The vaccine induces cocaine-specific antibodies that bind to cocaine in the blood and block its uptake in the brain. The pleasure response is altered and reinforcement of addictive behavior is reduced, allowing patients to interrupt the addiction cycle.

Depression with Anxiety – This medication is a result of recent discoveries connecting neurogenesis to central nervous system diseases. Neurogenesis is a process in which stem cells in the brain produce new brain tissue, including neurons. A neurogenic treatment can help neurons differentiate and survive. Since it does not affect serotonin levels, it could eliminate some of the negative side effects of typical antidepressants that act on serotonin.

Insomnia – A new medication in the development pipeline targets the protein orexin in the brain. Orexin regulates the sleep-wake cycle. By interacting with hormones, the drug could reduce or eliminate some of the side effects of current insomnia treatments. This medication induces sleep without affecting REM sleep.

Obesity – A medicine is in the pipeline that stops the pleasurable response to sugary and fatty foods and may contribute to weight loss in obese patients.

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Comments 14 comments

imatellmuva profile image

imatellmuva 5 years ago from Somewhere in Baltimore

WOW! This is a well put together, well informed, and... well, an awesome hub! I look forward to the day that clinical trials develop something that can be approved by the FDA, and with minimal side effects. One of my neighbor's father has alzheimers and he walked out of his daughter's home 11 days ago, and has yet to be found. I'm also interested in the drugs in the pipeline for mood disorder and depression. I try to follow this as close as I can. I have a family member who has a daily struggle with this. I understand that this can take years, and plenty of capital, but perhaps this is one that isn't too far from being approved and marketed.


kimh039 profile image

kimh039 5 years ago Author

Hi imatellmuva! Thanks for being the first to post a comment.... and for the compliments. That is so sad and scary about your neighbor's dad. I hope he is found. Sad to say, but I would imagine there is a lot of political pressure to find better treatments for alzheimer's just because of the expense to the governement. I can't believe your family member is still struggling daily with depression! I hope she finds something that works soon. If not, I hope she is open to ECT. Take care until next time, imatellmuva.


Happyboomernurse profile image

Happyboomernurse 5 years ago from South Carolina

Well researched and documented article that provides clear and concise information about the drug and development process in the US. I also liked the descriptions you gave of the new drugs currently being evaluated, which brings hope to those currently suffering from the diseases that you listed.

Voted up, useful, awesome and interesting.


Mentalist acer profile image

Mentalist acer 5 years ago from A Voice in your Mind!

If Research Can Reduce The Side-Effects Of A Treatment Then They Are On The Right Track...Thanks For Sharing Kim.;)


kimh039 profile image

kimh039 5 years ago Author

Thanks Gail. By the time I got to adding those the hub was a little long, but that was the purpose of writing it! I tried to set it up in a way that a reader could just look at the ones they are interested in, rather than read them all... although I think they are all pretty interesting.


kimh039 profile image

kimh039 5 years ago Author

Hi Mentalist acer! I would imagine there is stiff competition to be the first company to come up with the one that treats the symptoms without all those side effects - especially the antipsychotics. The one that treats "positive" and "negative" symptoms of schizophrenia without side effects looks really promising. I like the idea of a nasal spray for social anxiety too:)


d.william profile image

d.william 5 years ago from Somewhere in the south

Interesting and informative article. Thanks for sharing.


VENZKHVAM profile image

VENZKHVAM 5 years ago from Milk way galaxy, trying to find a more adventurous place in another galaxy with my great followers

WOW This is one helluva site for all the mentally affected peoples down there.

And this is a well researched and neatly put site.

And I bet this is full of fantastic information for the needy one.

All the anti psychotic is first of all very lucky to have all this in a brief with lots of explanation at least will give the educated relatives of the patents an idea.

very good hub well written.

voted up and useful.


kimh039 profile image

kimh039 5 years ago Author

Thank you d.william for reading and taking the time to comment. I appreciate it.


kimh039 profile image

kimh039 5 years ago Author

Hi Venzkhvam. Thanks for commenting. Many people who take antipsychotic medications are very intelligent and well educated themselves. I do hope friends and family members as well as consumers find the information helpful.


imatellmuva profile image

imatellmuva 5 years ago from Somewhere in Baltimore

kimh039, I am only here to say that your awesomeness is exceeded by even more AWESOMENESS!!!


kimh039 profile image

kimh039 5 years ago Author

@imatellmuva.....and the fact that you are aware of my awesomeness is exceedingly awesome. LOL. Thanks. (blushing)


vocalcoach profile image

vocalcoach 5 years ago from Nashville Tn.

kim - I would like to link this hub to my recent article on cyclothymia. Let me know if this is ok to do. Your hub contains valuable information and is well presented. I am bookmarking it and forwarding it on to friends and family. A big thanks for the research you have done! Voted up and across, except for funny. Hugs.


kimh039 profile image

kimh039 5 years ago Author

Of course that's fine, vocalcoach. I'm flattered. With your positive write up on the effectiveness of paxil, we might not need the 71 drugs in the pipeline for mood disorders! (I just said that you could vote funny too:) Best regards to you, and your friends and family vocalcoach.

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