Roche Laboratories today announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a New Drug Submission (NDS) to the Health Protection Branch (HPB) of Canada to seek approval to market Xenical(R) for patients who suffer from obesity. Xenical, a lipase inhibitor, is the first of an entirely new pharmaceutical class of non-CNS, non-systemic drug therapies for the treatment of obesity.

“This regulatory filing is the culmination of an intensive effort on the part of hundreds of Roche employees and physicians throughout the world, all of whom are working to improve the prognosis of patients who suffer from this chronic, relapsing medical disease affecting millions of Americans,” said Patrick J. Zenner, President and Chief Executive Officer. “We believe that Xenical will bring enormous value to the obesity community and we will continue to seek regulatory licensing throughout the world.”

The multicenter, placebo-controlled Phase III clinical trials involving nearly 5,000 obese patients studied the efficacy of Xenical when taken in conjunction with a mildly hypocaloric diet containing approximately one-third of all calories from fat. Xenical is the only treatment to date to have been evaluated in two-year clinical trials for weight loss, maintenance of lost weight, prevention of weight regain and improvement in co-morbidities including hypertension, dyslipidemia, impaired glucose tolerance and hyperinsulinemia compared to diet alone.

Xenical is an inhibitor of gastric and pancreatic lipases — enzymes that play a pivotal role in the absorption of dietary fat. Experts agree that excess caloric intake is a significant component in the development of obesity, and for many people, excess dietary fat is the largest component of this caloric excess. The action of Xenical against lipases blocks the absorption of approximately 30% of the fat eaten in food, which provides an additional caloric deficit for weight loss and control. In clinical trials, no major adverse side effects were noted. The most common effects reported were non-systemic and were primarily gastrointestinal, the majority of which were generally mild and temporary and frequently seen among patients who did not follow the appropriate diet regimen.

In the U.S., more than 70 million Americans are considered to be overweight and obese and are at high risk for hypertension, cardiovascular disease, non-insulin dependent diabetes, dyslipdemia, hyperinsulinemia and hypercholesterolemia. As little as 5% reduction in patients’ weight improves their health outcomes significantly.

Headquartered in Nutley, New Jersey, Hoffmann-LaRoche Inc. is an affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland. One of the world’s leading research-intensive companies, Roche has discovered, developed and introduced numerous important prescription pharmaceuticals.

Human resource is the most important resource of all resources. Howsoever developed the society is, without its human capital all other resources would lie redundant. The UK as a developed society has to preserve this capital from going haywire. Getting rid of obesity is one such step to be taken to keep this capital intact. And, use of order Xenical simultaneously with exercises and physical activities is one such method available to remove obesity which can result in the ultimate goal of saving that human resource

In that aspect coming of weight loss drug pills like order Xenical has been a boon for many obese individuals in UK. It got FDA approval in 1999 and has been in use since then for weight loss. The usage of Xenical by the large number of obese individuals from US prompted the obese persons from UK to use the diet pill to reduce obesity.Xenical works in the digestive system by blocking around a quarter to one-third of fat intake to reside in the body. When it is taken its molecule attaches with lipases and helps in blocking them to breakdown fat intake. As a result of which the excess fat is excreted.

The dosage for Xenical is a pill of 120mg with water along with the meal which contains fat. But along with the pill, exercises and a balanced diet should be taken to get the maximum result. A consultation with a doctor is required for taking this drug as this drug is a prescription drug. Particularly, pregnant women, breast-feeding women, children and, individual with heart diseases, stroke, allergy, diabetes and blood pressure should consult a doctor before taking the drug.

Anxiety, dizziness, nausea, stomach upset are some of the prominent side effects of Order Xenical (Orlistat). But these side effects subside once body adjusts to it. In case of these side effects or other side effects like vomiting, urination problems and fatigue etc. one should not shy away from a doctor.

Though it has its share of mild side effects Xenical is becoming a craze amongst obese persons in UK as it can reduce weight in a quite phenomenal manner.

Normal dose for Xenical uk diet pill is a 120 mg pill with every intake of meal or after it which contains fat. Precautions like intake of multivitamins 2 hours before or after meal should be taken as Xenical uk diet pill may disturb the break down of multivitamins too.

Obese individuals with diabetes, heart disorder, hypertension, etc. should consult a physician before taking Xenical. Breast feeding women and pregnant women should tell doctor about their status. In all it means before its medication health history of a person should be told to the doctor.

Side effects like increased number of bowel movement along with gas and oily discharge may be experienced during the entire course of Xenical diet pill’s intake. Other side effects may be encountered in event of that one should consult a doctor. To lead life to the fullest one has to maintain healthy food habits and do physical activities.

Xenical is one such diet pill which can reduce obesity when the dosage is combined with restricted diet regimen and exercises. Without both of these, the dosage of Xenical diet pill in reducing obesity would be wasted.

Xenical uk is a prescription medication intended to help moderately to severely overweight people in achieving their goals of weight loss and acquiring a healthier body. But Xenical uk doesn’t work the way most prescription weight loss pills work. Instead of curbing your appetite, it will do something quite different for you.

The fats we eat make up a very large proportion of our calories, and it makes sense that restricting fats will greatly reduce the amount of calories we take in. The trouble is that fats are what make our food taste so good. So, if you take all the fat out, we no longer get so much taste satisfaction.

Xenical Works in Your Digestive Region
Instead of working in your brain to block your feelings about food, Xenical works in your digestive tract where it attaches itself to the lipases which help you digest food. If the fat is not broken down by lipases, it cannot be absorbed, and it simply passes out of the body in the form of bowel movements. This means that a lot of calories that otherwise would have found their way into your system and add to your weight problem, are flushed out where they can do no harm.

It is important to realize, however, that a certain proportion of our diet must be from fat, because we use fat to make the hormones that make our bodies work. In addition, some of the fat soluble vitamins, such as vitamin A and vitamin E, will also be rendered useless to your body by Xenical uk. Never take more than the recommended dose of Xenical, which are usually three 120 mg doses daily. You won’t get any additional weight loss benefits from more Xenical, but you may lose many vital vitamins

What is Xenical Pill?
Xenical is an oral prescription medication that helps the body to eliminate unwanted fat. It is highly popular among the people who needed additional assistance beyond taking low-calorie diet and exercise. Study has shown that even low-calorie diet and exercise alone can not produce desired results. Since it is a prescription medication, it is advisable that you must show your medical history to the doctor to make sure Xenical pill are suitable for you.

Human body contains enzymes that break down the fats we eat. Xenical weight loss pills attaches itself to the enzymes, which prevents fats from being absorbed. In fact, it eliminated in your bowel movement. Xenical blocks up to 33% of the fat, which comes from the food you eat. This helps great in preventing from gaining access weight and encourages body to control weight naturally over long time.

Xenical Weight Loss Pill Results
In many medical tests, it was observed that patients who continued to take Xenical weight loss pills for one year had shown noticeable weight loss than those who did not use Xenical at all and remained on low-calorie diet or moderate exercise. Such patients could be able to shed weight approximately 6 lb whereas those who added Xenical weight loss pills to their low-calorie diets had significantly reduced weight approximately 13.5 lbs.

How to take Xenical Pill?
As said earlier, it is a prescription medication and you must share your medical history with your doctor. However, doctor generally prescribes Xenical pill to be taken three times daily during the meal. If not then maximum upto one hour after the meal. It is imperative to take with meals only because Xenical weight loss pills absorbs the fats produced by food and enzymes. If you wish to lose weight faster with Xencial weight loss pills then concentrate on eating low-calorie food only.

Before taking Xenical pill, inform your doctor about all the medicines you use (prescription and nonprescription) especially if you take cyclosporine, pravastatin, and warfarin. Consult with your doctor if you have an under active thyroid, chronic malabsorbtion syndrome or cholestatisis, gall bladder problems, gallstones, pregnant or breast feeding.

A 60 mg low-dose version of the prescription weight-loss medication orlistat (marketed by GlaxoSmithKline as Xenical 120 mg) was found to be safe, effective and tolerable in overweight individuals, according to new data presented today at the 2005 Annual Meeting of NAASO, The Obesity Society in Vancouver, British Columbia.
The study, which compared orlistat 60 mg plus diet to placebo plus diet in patients with a body mass index (BMI) of 25 to 28, demonstrates a statistically significant difference in weight loss. Orlistat patients who completed the four-month treatment period lost 5 percent of their baseline weight and diet alone lost 3.3 percent.

The randomized, placebo-controlled, 16-week study was conducted in a primary care setting, offered minimal intervention and was largely self-instructional. Approximately 36 percent of orlistat users and 28 percent of the placebo group (who used diet modifications alone) lost more than five percent of their initial body weight. Approximately 57 percent of orlistat users, compared to 42 percent of the placebo group, lost more than three percent of their initial body weight.

Orlistat patients also demonstrated significant decreases in total cholesterol, LDL cholesterol, systolic and diastolic blood pressure. Safety and tolerability of 60 mg orlistat in this population was similar to that observed in previous studies in a more overweight population.

“Prescription orlistat has been used successfully for years to help obese individuals lose weight and improve their health, so it’s exciting to find that a lower dose of orlistat can help those who are overweight with their weight loss efforts,” said lead investigator Dr. James Anderson, Professor of Medicine and Clinical Nutrition at the University of Kentucky. “The number of overweight individuals in this country continues to increase each year, and the risk of these folks progressing to obesity - and the resulting more serious medical problems - is significant.”source: uky.edu

XENICAL orlistat is available for oral administration in dark-blue, hard-gelatin capsules, with light-blue imprinting. Each capsule contains 120 mg of the active ingredient, orlistat. The capsules also contain the inactive ingredients microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc. Each capsule shell contains gelatin, titanium dioxide, and FD&C Blue No.1, with printing of pharmaceutical glaze NF, titanium dioxide, and FD&C Blue No.1 aluminum lake.

Orlistat (Xenical®)
Approved indication: Management of obesity in patients with a body mass index (BMI) > 30 kg/m2 or a BMI > 27 kg/m2 in the presence of other cardiovascular risk factors (e.g. hypertension, diabetes, etc.).Mechanism of action: Reversibly inhibits gastric and pancreatic lipases, decreasing the absorption of dietary fat (triglycerides) by about 30%.Pharmacokinetics: About 2% of orlistat is absorbed and this is mostly metabolized within the gastrointestinal wall. Most of the drug is excreted unchanged in the feces.

Evidence of effectiveness: Four double-blind RCTs are available to assess effectiveness.1-4 Three of these measured weight loss over a 1-year period in 1901 obese patients with and without Type 2 diabetes (BMI > 28 kg/ m2) eating a mildly hypocaloric diet.1-3 Pooled data from these 3 trials reveal that weight averaged 100 kg at baseline and 26.4% of patients withdrew during the first year. In patients completing one year of the trial, the mean decrease in weight with orlistat 120 mg tid was 8.9 kg vs 5.6 kg with placebo. The fourth trial studied the effect of orlistat on weight maintenance over a 1-year period.4 Obese subjects who had lost >8% of their initial body weight on a hypocaloric diet over a 6 month period were randomised to placebo or orlistat. During one-year follow-up, weight gain with orlistat 120 mg tid was 2.6 kg, significantly less than with placebo, 4.4 kg.Major adverse effects: Oily spotting, 27%, flatus with discharge, 24%, increased defecation, 11%, and fecal incontinence, 8%, occurred more commonly with orlistat than with placebo. More patients taking orlistat (14%) required vitamin A and D supplementation than patients taking placebo (6.5%).Dose and cost: Available in 120 mg capsules. Recommended dose: 1 capsule tid with meals (maximum duration 2 yrs). Daily cost: $4.38.

Conclusion: In obese patients orlistat in combination with a low-fat diet (<30% of calories) reduces body weight by 3.3 kg in the first year as compared to placebo

XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats.Orlistat XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial body mass index (BMI) >/=30 kg/m2 or >/=27 kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).

Basically, weight management is a complex and long process, and with the hardship of maintaining strict restrictions it can be frustrating as well. Fast paced professional and social lives leave little time for exercises or strict diets. Therefore, for these situations a safe medical solution is Xenical.

Xenical is a diet pill approved by the Food and Drugs Administration that helps in losing weight without any kind of side effects. But there are few strict precautions to be taken as you start using the medicine. The precautions basically should be followed while taking the medicine. As the basic safeguard, it has to be taken under the instruction of a doctor. However, there are also other detailed procedures and guidelines while one uses the medicine regularly.

It is not just the use of Xenical however, that will be sufficient to meet your objective. Infact, the whole process of weight loss depends on the way a person leads his or her life. It is determined by the way he regulates his diet and maintains the body strength through regular exercise.

There is a vital question that arises here, how will someone understand that he or she is suffering from obesity? A person is considered to be obese when his or her BMI, that is Body Mass Index, is 30 or more. The BMI depends on the quantity of fat in the body. Therefore, before recommending the Xenical, the BMI is checked by the doctor. It is usually done by considering and measuring the weight, height and other information regarding any kind of illness.

Xenical not only helps in weight loss but it also has other benefits too:

- As compared to other pills of such kind, Xenical capsules keep obesity off for a longer time.

- It improves the dietary habit as it works in combination with a proper diet to be maintained strictly.

- It increases the physical strength of a person, as regular exercise should be combined with the intake of the medicine.

- It also prevents weight gain after prior weight loss.

- It is effective even if the person has hypertension, and diabetes.

- This diet pill, moreover, reduces the chances of the heart diseases by lowering the cholesterol in the body.

What are some possible side effects of Xenical? (This is NOT a complete list of side effects reported with Xenical. Your health care provider can discuss with you a more complete list of side effects.)

• Oily spotting
• Gas with discharge
• Urgent need to have a bowel movement
• Oily or fatty stools
• Oily discharge
• Increased number of bowel movements
• Inability to control bowel movements

For more detailed information about Xenical, ask your health care provider.

Xenical diet pill Side effects 2

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Headache
Oily spotting from the rectum
Abdominal pain or discomfort
Flatulence (wind) with discharge
Oily or fatty stools
Urgent or increased need to open the bowels
Diarrhoea
Pain or discomfort in the rectum
Infections of the airways
Low blood sugar levels (hypoglycaemia) in people with diabetes
Faecal incontinence
Fatigue
Urinary tract infection
Irregular menstrual cycle
Anxiety
Tooth or gum disorders
Diverticulitis
Gall stones
Raised liver enzymes
Inflammation of the liver (hepatitis)
The side effects listed above may not include all of the side effects reported by the drug’s manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

What are the side effects of Xenical diet pill? (part 3)

The most commonly reported side effects of Xenical diet pill include stomach pain and discomfort, gas, an urgent need to move the bowels, fatty or oily stools, oily rectal discharge, diarrhea, and a loss of bowel control. You’re more likely to have these side effects with higher doses of medicine and with a high-fat diet.These side effects go away in most people after 4 weeks of therapy, but it can continue for longer than 6 months in some individuals. If these side effects continue or get worse, you should talk to your health care provider.Do not use Xenical diet pill if you have problems absorbing food, gallbladder disease, or eating disorders such as anorexia or bulimia.