Depression, Anti Depressants, Antidepressant Medications

04 Jan

Pfizer Halts Phase III Trial On Obesity Drug Over US Rejection Fears



THURSDAY, Oct. 23 — Women who are depressed early in their pregnancy run a higher risk of preterm delivery, the leading cause of infant mortality, a new study suggests. For the study, researchers interviewed 791 San Francisco-area women near their 10th week of pregnancy. Forty-one percent reported “significant” symptoms of depression, and 22 percent reported “severe”

Full Post: Depression During Pregnancy May Cause Premature Birth

Pfizer Inc., the world?s largest drugmaker, on Wednesday said it abandoned an obesity drug known only by the designation CP-945,598 ? not specifically for safety concerns but because of ?changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval.?

?While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities,? Martin Mackay, president of Pfizer Global Research and Development, said in a statement.

The drug was in the third of three stages of testing required for market clearance and could have more than $500 million in annual sales, according to analysts.

The drug works by blocking the same brain receptor that makes marijuana smokers hungry, a process the FDA considers dangerous, as it could increase the risk for other health conditions including mood disorders and neurodegenerative disorders such as multiple sclerosis.

Pfizer?s announcement comes a months after Merck & Co. announced its decision to cancel further investigation into its experimental obesity drug called taranabant because of side effects uncovered in clinical trials.

The company said that both effectiveness and side effects were dependent on dose levels; at more effective dosages, the side effects climb too much. The side effects associated with the drug taranabant were psychiatric, including anxiety and depression.

Taranabant is also a cannabinoid-1 (CB-1) receptor inverse agonist, which means it works by blocking cannabinoid receptors in the brain and it suppresses appetite. Cannabinoid receptors are the same receptors that make people hungry when smoking marijuana.

In 2007, Sanofi-Aventis? anti-obesity drug, generically known as rimonabant (Acomplia) was also rejected by the Food and Drug Administration in the United States due to concerns about the risk of suicidal thoughts and depression among some users. According to a series of studies, not only does the obesity drug increase the risk of depressed mood disorders and anxiety, but it is also almost ineffective against obesity, as people lose less than 5 percent of their total body weight.

At the end of October, the European Medicines Agency announced that the risk of serious psychiatric disorders and even suicide are too high in patients taking Acomplia. The European Medicines Agency recommended pulling the drug from the market because of its side effects.

The agency had concluded that ?the benefits of Acomplia no longer outweigh its risk? and there was an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia versus a placebo. Data from recent studies has shown the side effects were even higher. Between June and August 2008 there were five suicides among participants in the trial who took the drug, compared to one among those taking a placebo.

Source

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28 Dec

Pfizer Halts Phase III Trial On Obesity Drug Over US Rejection Fears



Stress and increased work load on human brain leads to severe sorts of depression and anxiety that would ultimately lead to imbalanced homeostasis, the natural tendency of the body to stay constant. Apart from the natural protective mechanisms of the body, such disorders could be cured by latest available drugs. One of the most effective

Full Post: Say no depression with Zoloft

Pfizer Inc., the world?s largest drugmaker, on Wednesday said it abandoned an obesity drug known only by the designation CP-945,598 ? not specifically for safety concerns but because of ?changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval.?

?While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities,? Martin Mackay, president of Pfizer Global Research and Development, said in a statement.

The drug was in the third of three stages of testing required for market clearance and could have more than $500 million in annual sales, according to analysts.

The drug works by blocking the same brain receptor that makes marijuana smokers hungry, a process the FDA considers dangerous, as it could increase the risk for other health conditions including mood disorders and neurodegenerative disorders such as multiple sclerosis.

Pfizer?s announcement comes a months after Merck & Co. announced its decision to cancel further investigation into its experimental obesity drug called taranabant because of side effects uncovered in clinical trials.

The company said that both effectiveness and side effects were dependent on dose levels; at more effective dosages, the side effects climb too much. The side effects associated with the drug taranabant were psychiatric, including anxiety and depression.

Taranabant is also a cannabinoid-1 (CB-1) receptor inverse agonist, which means it works by blocking cannabinoid receptors in the brain and it suppresses appetite. Cannabinoid receptors are the same receptors that make people hungry when smoking marijuana.

In 2007, Sanofi-Aventis? anti-obesity drug, generically known as rimonabant (Acomplia) was also rejected by the Food and Drug Administration in the United States due to concerns about the risk of suicidal thoughts and depression among some users. According to a series of studies, not only does the obesity drug increase the risk of depressed mood disorders and anxiety, but it is also almost ineffective against obesity, as people lose less than 5 percent of their total body weight.

At the end of October, the European Medicines Agency announced that the risk of serious psychiatric disorders and even suicide are too high in patients taking Acomplia. The European Medicines Agency recommended pulling the drug from the market because of its side effects.

The agency had concluded that ?the benefits of Acomplia no longer outweigh its risk? and there was an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia versus a placebo. Data from recent studies has shown the side effects were even higher. Between June and August 2008 there were five suicides among participants in the trial who took the drug, compared to one among those taking a placebo.

Source

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Related Posts:


Stress and increased work load on human brain leads to severe sorts of depression and anxiety that would ultimately lead to imbalanced homeostasis, the natural tendency of the body to stay constant. Apart from the natural protective mechanisms of the body, such disorders could be cured by latest available drugs. One of the most effective

Full Post: Say no depression with Zoloft
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Effexor is an effective medicine that treats anxiety, depression and panic disorders. Effexor is an antidepressant, which belongs to Selective Serotonin and Norepinephrine Reuptake Inhibitor (SSNRIs). The medicine should have to be taken with food. Once you are prescribed Effexor, follow the prescription strictly. Never take larger doses or take the capsules for longer periods unless

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Paxil is an effective medicine prescribed for the treatment of depression, social anxiety disorders and posttraumatic stress. A Selective Serotonin Reuptake Inhibitor, Paxil acts on Serotonin, a natural chemical in the brain that determines the mood of a person. The drug restores the balance of Serotinin, which helps in bringing back the mood of a

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Celexa drug is used for treating depression. It is a Selective Serotonin Reuptake Inhibitor. The medicine acts on serotnin, a substance in the brain that is responsible for mood changes. Celexa should only be taken as per the prescription; do not take larger amounts or take the drug for longer periods. Once you have started

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Cymbalta is used for the treatment of depressions and anxiety disorders. It is also prescribed for diabetic peripheral neuropathy. Cymbalta belongs to a group of drugs called Selective Serotonin and Norepinephrine Reuptake Inhibitors. The drug works on the chemicals in the brain, which brings in mood changes. The drug can be taken with food and

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