A Week Long Acting Diabetes Medication In Approval Process

A competition to grab market of long acting diabetes medication is likely to occur if FDA approves extended version of Exenatide. Exenatide is generic for Bytta. Extended Exenatide is known as Bydureon. FDA has already issued response letter for extended exenatide.

Bydureon is brand name of extended exenatide. The earlier short acting version Bytta (brand name for exenatide) was approved in 2005 for treatment of Type 2 diabetes. Bydureon is once a weekly drug, that is, signgle dose taken in a week would keep producing equivalent therapeutic effects of Bytta throughout the week.

Another such drugs under approval process is Taspoglutide by Roche and Albiglutide by GlaxoSmithKline. These all diabetes medications are modified to stay in body and keep controlling diabetes for 6-7 days instead of hours.

Long action of these drugs is because of half life of active ingredient. Half life of active ingredients of these drugs is 6-7 days. The drug will keep producing its intended therapeutic effects as long as it stays in human albumin.

Taspoglutide, as declared by Roche, has shown great result in phase 3 trial conducted to acquire approval by FDA. If everything goes well in trial, Taspoglutide would hit USA market in 2011.

FDA has set 22 October 2010 to collect fee for fund Bydureon approval process. Other examinations such as manufacturing process clarification, prescribing information and risk study is likely to finish by 2011.

New Lipitor Alternative May Get Launched Soon

Lipitor (Atorvastin) is most successful cholesterol lowering drug across the world. Apotex Inc, based in Canada, announced that it would launch its own cholesterol lowering drug equivalent to lipitor. Lipitor was approved by FDA on 27 Sep 2005 for treatment to lower cholesterol level. Being the fact that Lipitor is still patened and no company can produce its generic version, patients are paying high cost for lipitor.

Alone in canada lipitor sales reached to 1.2 billion USA dollar last year. The canadian firm has said that the drug woud serve as generic replacement for lipitor. The new drug would be made of 'crystal form' which will help to bypass current patent rights of Pfizer on lipitor and help patients across the canada to use cheaper version of lipitor. Not only that but the drug will also represent bio-equivalency of lipitor.

However, Apotex Inc is likely to face challenge as Pfizer owns subsidiary rights to make generic substitute of its brand lipitor.

New Inhaler Drug may Help get Erection in 10 Minutes

A study published in Journal of Sexual Medicine, indicated apomorphine inhaler caused erection within 10 minutes. The researchers came across the fact while studying new treatment for another disease. 600 men were being examined to study the effects of apomorphine inhaler.

Apomorphine inhaler could be new treatment for impotency without most shortcomings of many impotence drugs in market such as viagra, cialis and levitra.

Apomorphine, like priligy, is a non-selective dopamine agonist which activates receptors. In inhaler apomorphine is in powder form. Before this fast acting treatment hits market, as erectile dysfunction remedy, it needs to go under trials to acquire FDA approval. Scientists and researchers at pharmaceutical companies are very much optimist for it to be one of the most effective and fastest treatment for impotence.

Popular erectile dysfunction drugs, such as cialis generic levitra viagra, in market takes 40 minutes or an hour to act i.e. men have to take those drugs 1 hour before sexual intercourse.

Effects of viagra or cialis or levitra vary from person to person. The drugs have been great for some men and little or of no use for others. For men with whom those drugs do not go well, only FDA approved options are inject drugs directly to penis, or a pump to increases blood supply to penis.

Labeled usage (i.e. approved by FDA) of apomorphine is in treatment of Parkinson's disease. A trial conducted by experts of Vetura Ltd found the new effect of apomorphine.

Viagra and Levitra Can Help Enhance Brain Tumors Treatment

Drugs that are being used to gain penis-erection are helpful to enhance working mechanism of Herceptin, a cancer drug. In order to treat brain tumors, a drug must get through the blood-brain-barrier to prevent cancer to other healthy cells of brain. A research, by Dr. Keith Black at Cedars-Sinai’s Maxine Dunitz Neurosurgical Institute, found that drugs like viagra and levitra can help anti-cancer drug to reach cancer-infected cells.

Blood-brain barrier is separation of blood and brain fluid (cerebrospinal fluid or CSF). Brain stays almost afloat in this fluid. This separation occurs in all capillaries with the help of a junction. Separation keeps harmful and toxic substances away from brain.

To prevent metastasization (process where one cancerous cell infects other cell) of brain, cancer drug has to penetrate this barrier. This barrier makes it difficult to treat tumor as it prevents drug chemical to reach brain.
Dr. Black, who's been studying the blood-brain barrier for about two decades, believes this finding will have major impact on the way brain tumor is being treated. According to Dr. Black chemotherapy drug (doxorubicin) and anti-cancer drug (Herceptin) will have little or no effect unless they can break into Blood-brain barrier.

Viagra and Levitra increases permeability and help large molecule anti-cancer drug, such as Herceptin, to cross the barrier and reach the target cells.

Dr. Black and his team conducted a research on Mouse. They found that delivery of Herceptin increased by two fold when given with Sildenafil Citrate (Viagra).

Nutraceutical Lowers Cholesterol Level

Scientists have found nutraceutical that helps to lower cholesterol level. Result of small trial, published at EuroPREVENT 2010, showed significant cholesterol lowering effects. Dr Valentina Mercurio (University of Naples Federico II School of Medicine, Italy) used three foods namely; red yeast rice, berberine and policosanol to study their combined therapeutic effects.

Dr Valentina refers this as nutraceutical. Nutraceutical is use of food that serves medical or health benefits through its naturally occuring elements.

The reason these foods attracted scientists was their traditional use as cholesterol lowring agent in India, china and other non-western countries. Many studies are going on to find out a substance in all these foods that lowers cholesterol.

Nutroceutical Cholesterol Lowering Substances

Red Yeast Rice
Red yeast rice is rice with yeast grown by fermetation. It has "monacolins", a single name to refer a coumpond of several substances it (monacolins) is made up of. Monacolins prevent process that produces cholesterol. Out of many other coumpounds in monacolins, monacolins K is strongest coumpond capable to inhibit cholesterol forming process. Monacolin K is a potent inhibitor of enzyme, known as HMG-CoA reductase, responsible for cholesterol synthesis. A top selling cholesterol medication lovastain (brand name Mevacor) is notheing but a monacolin to treat hypercholesterolemia. Monacolin is biological name and lovastatin is pharmaceutical name. Red yeast rice on Mayoclinic
Berberine
It is a quaternary ammonium salt made up of four other substances. In bio-chemistry Berberine has been placed into group of isoquinoline alkaloids. Berberis plant is prime source of Berberine. It is also found in roots of other plants such as goldenseal (Hydrastis canadensis) and Coptis chinensis. Other therapeutic usage of Berberine is in Diabetes, dyslipidemias and heart problems. Berberine Wikipedia
Policosanol
Policosanol is extract of plants. It is being derived from the waxes of plants such as beeswax, sugarcane or yams. Policonsanol increases good cholesterol and decreases bad cholestrol level. Policosanol Wikipedia

Brief of Trial Study
Study was conducted on 50 hypercholesterolemic patients. Patients were devided in two groups. One group was given oral dose of nutraceutical combination (500-mg of berberine, 200-mg of red yeast rice, and 10-mg of policosanol) and second group was given placebo for a six-week period daily. After completion of first six weeks all patients were given only nutraceutical product for four weeks.
LDL cholesterol (bad cholesterol) level was seen same in patients administered with placebo. LDL cholesterol level in patients of group administered with nutraceutical product was significantly lower than previous level. Blood flow in blood-vessles, known as Dilation, also improved by 3% in nutraceutical products.

Pramipexole: Depression Medication for Parkinson's Disease Patients

A small clinical trial, conducted by Dr Paolo Barone, suggests that dopamine agonist helps to treat depression of Parkinson's patients. Dopamine agonist, such as Pramipexole, may specifically treat depression of patients of parkinson's disease. Conclusion was published on TheLancet Neurology May 10 edition.
Experts believe that depression in parkinson's disease is caused by malfunction path where domaine is being transmitted from one point to another. Although depression symptoms are found in nearly 35% of patients suffering from parkinson's disease, few studies and researches have been made on depression medication to treat it. Dopamine agonist is already being used to treat severe depression. It is learnt from the trial that Pramipexole shows direct antidepressant effects in Parkinson's disease.

Pramipexole is drug of class dopamine agonist used to treat parkinson's disease. Pramipexole is also being used to treat sexual problem caused by usage of antidepressants. Pramipexole has shown strong effects in bipolar disorder.

Effect of Pramipexole found to be double-in-action, that is, it independently treats both Motor Disability and depression. The found result of the study, positive effects of single drug on two major diseases, is considered to be very important for further studies.

Pramipexole Works?
Parkinson's is a neurodegenerative disease which affects the part of the brain (substantia nigra) responsible for body movements. The substantia nigra, located around basal ganglia, contains high level nerve cells that release neurotransmitters called dopamine. Dopamine activates its receptors in basal ganglia (a part of brain). In parkinson's disease part of brain that contains dopamine neurones does not produce enough neurones. This causes lack of dopamine signals which results in lost control of brain on movements. Pramipexole works by stimulating the malfunctioning dopamine receptors in the striatum, thereby restoring the dopamine signals needed for proper functioning of the basal ganglia.

Generic Namenda Approved By FDA

Namenda was first approved by FDA in 2003 for treatment of alzheimer. It was first patened as Namenda by Forest Labotateries. FDA has approved generic version of Namenda to Sun Pharmaceuticals.

Memantine Hydrochloride is generic for Namenda. Other brand names for Namenda are Axura and Akatinol, Ebixa and Abixa and Memox. Namenda is prescription drug, it means patients are needed to provide valid prescription to buy this drug.

How Does Namenda Work?

Namenda is the only drug of class selective NMDA glutamate receptors antagonist.

It works by blocking attachment of glutamate to NMDA receptors. Improper functioning of glutamatergic neurotransmission is believed to cause Alzheimer's disease.

A pathological process in which glutamate damages or kills nerve cells is referred as Excitotoxicity in medical. Excitotoxicity = Improper functioning of glutamatergic neurotransmission.

Namenda works by releasing memantine which prevents activation of glutamate by sticking to NMDA receptors. High concentration of glutamate, caused by high level of CA2+ ions, disturbs physiological function of the receptor. Memantine prevents excess level of Ca2+ ions by preventing activation of glutamate.

Namenda Side Effects

Side effects of Namenda were found well tolerable in clinical trials. Namenda
side effects include......

1. Confusion


2. Dizziness


3. Drowsiness


4. Headache


5. Insomnia


6. Agitation


7. Hallucinations

Other rare side effects are anxiety, vomiting, increased muscle tension, infection of the urinary bladder (cystitis) and increased libido.

'High cost of Namenda overcomes its benefits' was the reason cited by UK's National Institute for Clinical Excellence for not recommending use of the drug. Now that generic for Namenda is available it will be of great aid to Alzheimer patients.

McNeil Called Off Tylenol, Motrin and Zyrtec; Use Generic

McNeil pharmaceutical recalled Tylenol, Motrin and Zyrtec syrup from market. FDA team, while on inspecting j&j plant in Fort Washington; Pa in April, found raw materials being used were contaminated. Certain bacterias were found that could cause infections.

Contaminated raw materials that were supposed to be used for manufacturing some of kids and infants syrup medicines such as tylenol, zyrtec and motrin suspension. FDA official cited saying that although used raw materials were contaminated, produced drug did not show any contamination.

Johnson & Johnson, followed by FDA inspection result, called off thousands of pediatric syrup bottles of Tylenol, Motrin, Zyrtec and Benadryl.

Taking 40 consumers complaints into consideration, FDA commissioner have asked consumers to use generic version of respective drugs.

Quistion rifed around is would consumers get back to brand? As discussed by John Mack, McNeil pharmaceutical silo of j&j may come to rescue j&j, but j&j would not be unhurt at all.

Treating Depression Without Depression Medication

Working of brain is largely of transmitting and receiving electric signals carried by neurotransmitters. Specific signals by particular neurotransmitters indicate specific feelings. In regard with this scientists have developed an electric device known as TMS (transcranial magnetic stimulation). TMS device is used to provide daily dose of electric signals to certain parts of brain. The device has been approved by FDA, on October 2009, to treat depression.

Even after FDA approval, some experts were doubtful for effectiveness of the device to treat depression. Concerns of skeptics were legitimate as there was no way to fake signals. In order to acquire approval of a drug from FDA, applicants are required to prove effects of drug with series of clinical trials conducted with original-drug and a placebo (placebo = a drug that has no effects). Until now, there was no device which could work similar to real TMS device but produce no effects.

Dr. Mark S. George, head of the study, developed a device which can give sound and sensation similar to real TMS but has no effects. Results and conclusions of the study were published on Archives of General Psychiatry in issue of month May.

Conducted study included 190 patients divided in two groups. Patients of first group were treated with real device and group second with fake device. Patients were subjected to real TMS device for 37.5 minutes and 37.5 minutes to dummy device. All 190 patients were given dose for 3 weeks, once a day.

The trial showed 26 patients recovered from depression while, on the other hand, 9 patients showed recovery signs from their depression with dummy device. Recovery signs of patients with real TMS were four times greater that that of dummy device.Side effects, such as discomfort; headache and eye twitching, were reportedly same in both the groups.

57 patients recovered from depression in second phase trial conducted on all patients treated with real device.

Dr George and his team are now studying effects of antidepressant effexor and effects produced by TMs device.

What causes Depression
Neurotransmitters, responsible for good mood, carry signals to brain. Lack of such transmitters cause lack of signals and lead to depression. Anti depression medication, such as effexor, works by preventing re-absorption of neurotransmitters that regulate good mood. Stopping re-absorption increases level of neurons and thus increases signals of good mood.

TMS device works by resetting electrical imbalance of signals and restores normal mood.
Depression Medication

Drugs for Erectile Dysfunction Treatment

Many men get confused when they have to pick drug for erectile dysfunction. Needless to say consumers are looking for best deal that is, ED drug with best effect, lowest price and less side effects.

When it comes to erectile dysfunction drug, name that pops up in our mind are Viagra, Cialis, and Levitra. These all drugs belong to same class of Erectile dysfunction drug called PDE5 inhibitors. They work in nearly same way to help achieve erection. However, cialis levitra viagra differes in few matters. Matters, such as time erection last, side effects and time to show effect.Cialis would fit to most of the men's requirements if a comparison is made between cialis generic levitra and viagra drug to figure out best medication.

See below chart to compare cialis generic levitra viagra.

[Note: All three drugs has many side effects (common to rare side effects). Only side effects that are distinct are listed here of cialis levitra and viagra.]

Cialis Cilais contains Tadalafil as active ingradient. Works in 30 minutes Cialis gives longest erection. Effect (Erection) last for 36 hours Cilais is product of Eli Lilly and Company Shape: Egg shape; Color: Orange. Price per pill: $1.86 Cialis side effects includes hearing problem

Viagra Viagra contains Sildenafil Citrate as active ingredient Works in 1.5-2.0 hours. Viagra gives erection till 4-5 hours Viagra is product of Pfizer Shape: Qudrilateral round corner; Color:Blue. Price per pill: $2.80 Viagra side effects include blurred vision and hearing problems

Levitra Levitra contains Verdenafil as active ingradient Works faster than viagra. Levitra shows effects within one hour. Duration of erection obtained by Levitra is 4-5 hours. Levitr is product of Bayer AG Shape: Round; Color: Orange. Price per pill: $3.5 Levitra side effects include hearing problems and vision problems such as blurred vision

Provenge Sipuleucel-T Information Side Effects

Last week Provenge finally got approval as vaccine for final stage of refractory prostate cancer. Provenge is launched by Dendreon for autologous cellular immunotherapy treatment of prostate cancer in certain men.

What is Provenge (sipuleucel-T)

Sipuleucel-T is generic for Provenge. It is not kind of any tablets. Provenge is vaccine used along with patient's immune cells collected and infused, with the help of leukapheresis process, in body system.

Prostate cancer
Prostate cancer occurs when a tumor (a tumor is rapid and abnormal growth of tissues) in prostate gland invades and destroys near by tissues and spreads to other tissues. Prostate gland, when most of the tissues are infected, fails to work normally.

Prostate cancer is associated with growth of male hormone called testosterones. DHT (Dihydrotestosterone) is needed for cancer cells to grow. DHT are converted from testosterone. Hormone (also known as analogs) therapy is used to block production of testosterone. Medicines of class antiandrogens are used to block conversion of testosterones into dihydrotestosterones. Thus, overall effects result in prevention of growth of cancer cells.

Provenge is indicated to treat refractory prostate cancer. Prostate cancer is refractory when body does not respond to hormone therapy. Provenge is an autologous cellular immunotherapy, is made up of patient's own immune cells to stimulate immune system.

Patient's cells are collected at the authorized center before 3 days of beginning of therapy.

Side Effects of Provenge

Common Provenge Side Effects

Provenge side effects includes chills, fatigue, fever, weakness, shortness of breath, wheezing, low oxygen level, dizziness, high blood pressure, headache, muscle pain, vomiting and nausea.

Serious Provenge Side Effects

Seek emergency help if any of the following side effects occur......

• Breathing problems


• Chest pains


• Racing heart or irregular heartbeats

Symptoms such as nausea, dizziness, or vomiting are may related to heart or lung problems.

Provenge Dose

Therapy requires three dosages of Provenge.

Precaution to take while Provenge Therapy

Let your doctor know your medical history such as heart or lung problems or history of stroke.
Brief your doctor about all the prescription drugs, OTC drugs, vitamins, and dietary supplements name you are taking. You doctor may suggest to stop particular medications.
Infection may occur at the site of infusion or the place where cells were collected from. Seek help from your doctor you notice redness at operated site; get a fever over 100°F.