Arena Pharmaceuticals Submits Application for New Weight Loss Drug Lorcaserin

Arena Pharmaceuticals, Inc., based in San Diego, CA, announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, a new drug candidate for weight management, including weight loss and maintenance of weight loss.

The company has had the medication in 18 clinical trials involving over 8,500 patients. The Phase 3 clinical trial program, called BLOOM (Behavioral Modification and Lorcasering for Overweight and Obesity Management) and BLOSSOM (Behavioral Modification and Lorcaserin Second Study for Obesity Management) evaluated approximately 7,200 patients treated for up to two years with 10 milligrams of lorcaserin, and consistently produced significant weight loss with excellent safety and tolerability.

William R. Shanahan, M.D., Arena’s Vice President and Chief Medical Officer, stated, “Physicians need new, better-tolerated approaches to improve the treatment of patients who are obese or significantly overweight. Based on the robust data package we submitted to the FDA, lorcaserin has the potential to meet this need, offering patients the opportunity to achieve sustainable weight loss in a well-tolerated manner and improve their cardiometabolic health and quality of life.”

Lorcaserin works by stimulating the serotonin receptors in the hypothalamus of the brain, which is strongly associated with feeding behavior and satiety. Indications for patients who would be appropriate candidates for lorcaserin include those with a body mass index (BMI) between 30 and 45 with or without co-morbid conditions, or patients with BMI between 27 and 29.9 with at least one medical condition affected by obesity, such as hypertension or type 2 diabetes.

Two other companies are competing with Arena to become the first prescription weight loss drug approved in a decade. Vivus Inc is currently in a late-stage clinical trial with its drug called Qnexa, a combination of phentermine and an epilepsy medication called topiramate. Orexigen Therapeutics Inc plans to file for approval next year for its drug Contrave, which combines the antidepressant Wellbutrin with naltrexone, and opioid blocker used to treat alcoholism.

The Centers for Disease Control estimates more than a third of U.S. adults are obese. But pharmaceutical companies have had difficulty developing weight loss medications because of significant side effects which need to be minimized for the drugs to be used over a long period of time. The most common side effects of prescription weight loss drugs include increased heart rate, increased blood pressure, insomnia, gastrointestinal distress, or headache.

Currently, there are only two prescription drugs approved by the FDA for long-term weight loss. Meridia (sibutramine) made by Abbott Laboratories also works on the serotonin receptors in the brain to promote satiety and reduced calorie intake. Xenical (orlistat) made by Roche prevents the absoprtion of fat in the intestine. Alli is a reduced strength version of orlistat and available over-the-counter. Adipex-P (phentermine) is another approved medication, but should only be used for a short period of time, generally less than 12 weeks.

Weight loss drugs are not intened to be used as a stand-alone treatment for obesity. Dieters must still follow a low-calorie diet and regular exercise to maximize weight loss.

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Juice Recipes For Weight Loss Are Getting More Popular

Juicing for weight loss took the main stage a few years ago with the introduction of the Jack LaLanne Power Juicer. Juice recipes for weight loss are getting more and more popular each and every day and that’s because of the nutrients and vitamins each drink contains not to mention how filling they are.

Drinking juice for weight loss is meant to be a jump-start to the lifestyle change of losing the pounds and can be introduced as a part of your daily routine over a 2 week period. Try substituting an entire meal with either of the juice recipes below. Even one meal like this a day will decrease your calorie count greatly and help your weight melt away. Try your new juice diet for a short period of time in order to lose several pounds quickly. It is not a long-term solution, however!

Juice recipes are easy if you stick to foods you know you enjoy plus, you’ll be unlikely to discover a juice you don’t like. To get rid of food cravings try a fresh juice with parsley and carrot juice since these are natural appetite suppressants. Juice recipes for weight loss are a great and simple way to get healthier and feel good doing it.

Instead of taking all those diet pills that claim to contain antioxidants, fruits and vegetables are a healthy substitute to these pills. The juices also take away the toxins from the body thus leaving a healthier and smarter you. Vitamins and minerals found in fruits and vegetables are agents for weight loss and a good way of losing weight while going natural.

All it requires is the small investment of a juicing machine and a book full of delicious recipes. You’ll never need to stop at the smoothie stand or drink store bought juice which has a fraction of the nutrients you need on a daily basis.

Strawberry Raspberry Blend

* 1 cup strawberries, washed and chopped

* 1 cup raspberries, washed and chopped

* 1 glass mineral water

* crushed ice, as required

1. Liquify the raspberries and strawberries in a blender.

2. Pour over crushed ice.

3. Serves 1 with only 110 calories!

Blueberry Blast Breakfast Smoothie

* 2/3 cup frozen blueberries or fresh blueberries

* 1/2 cup organic vanilla yogurt (can use fat free)

* 1 banana

* 1/2 cup cold fruit juice, your choice (we use blueberry, raspberry or white grape juice)

* 1 tablespoon wheat germ

1. Put ingredients in a food processor or blender and pulse until it is your desired consistency.

2. For a thicker shake or if you use fresh berries add a few ice cubes.

3. Serves 1 with only 327 calories!

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Weight-Bearing Exercise Throughout Pregnancy Boosts Heart Health

We know that exercise throughout life boosts heart health. Many women stop exercising during pregnancy. According to the results of a new study, weight-bearing exercise throughout pregnancy can help women maintain cardiovascular health long-term.

According the results of a study published in the November 2008 issue of the American Journal of Obstetrics & Gynecology…”the specific long-term effects of continuing regular weight-bearing exercise during pregnancy are unknown.” James F. Clapp III, MD, from Case Western Reserve University School of Medicine in Cleveland, Ohio investigated women before, during and 1 year after pregnancy, beginning 18 to 20 years ago.

A follow-up study was then conducted of 39 women at the General Clinical Research Center at the University of Vermont, examining the women’s cardiovascular risk profile. Comparing women who stopped exercise during pregnancy, the study showed that women who continued, had better overall heart health, gained less weight, and experienced a higher level of overall fitness. Women who exercised during pregnancy were also more prone to increase exercise over time, and continue on a regular basis. Previous studies have not supported the long-term benefits of heart health in women from exercise during pregnancy.

All of the 39 women exercised regularly. Nineteen of them either stopped or limited the amount of exercise they performed before their twelfth week of pregnancy, but started again after delivery. The women’s heart function was measured before, during and after pregnancy.

Maintaining heart health can be difficult for women before and after menopause. The risk of heart disease increases as estrogen levels decline. The study group included in Dr. Clapp’s analysis performed vigorous exercise, and continued long-term. Exercises included cross country skiing, running and aerobics.

Dr. Clapp writes, “Women who continue weight-bearing exercise during pregnancy maintain their long-term fitness and have a low cardiovascular risk profile in the perimenopausal period.” This is the first study that shows women can maintain heart health long-term, by continuing weight-bearing exercise throughout pregnancy.

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More Women Seek To Be Thin During Pregnancy

Remuda Ranch Programs for Eating and Anxiety Disorders, the nation’s leading eating disorder treatment center, reports there’s a new pressure to look perfect while pregnant.

“With the media giving so much focus to pregnant celebrities, there’s an increased pressure to look perfect and thin during pregnancy,” said Brenda Woods, MD, director of medical services at Remuda Ranch. “Our society’s ‘thin’ ideal has crossed over to pregnant women. Many women are feeling the pressure to not gain too much weight during pregnancy and to lose their pregnancy weight very quickly. Also, it’s important to note that adolescents with eating disorder histories are in their reproductive years.”

Remuda Ranch reports some of the warning signs that a woman is suffering from an eating disorder while pregnant include:

* Failure to gain weight while pregnant
* Poor fetal growth
* Exercise beyond what is healthy while pregnant

If a woman is suffering from an eating disorder while pregnant, she faces many medical complications including: low birth weight in the infant; possible neurological damage to the baby; increased caesarean section rate; and increased miscarriage early in pregnancy.

“A woman with a history of an eating disorder may be more vulnerable during pregnancy,” adds Dr. Woods. “The emotional stressors of facing parenthood may push a woman with a history of an eating disorder back into those behaviors.”

Normal weight gain is 25 to 40 pounds during pregnancy for a woman who is already at a healthy weight. The numbers range from 35 to 50 pounds for an underweight woman. These numbers can cause extreme anxiety for women with eating disorders.

“Women need to be educated about what’s normal when pregnant,” said Dr. Woods. “Doctors need to screen pregnant women for eating disorder beliefs and practices. Pregnancy is a great time to make changes that will not only help you, but also guarantee a better future for your child.”

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Health and Beauty Products are Included in Target Black Friday Preview Ad

Target is among the many retailers gearing up for Black Friday, the most popular shopping day of the year. As people generally get a 4-day weekend for Thanksgiving, many use the opportunity to kick off their holiday season shopping on the Friday after Thanksgiving day. Target is offering a preview of the items they will have for the 2010 Black Friday sales.

Under health and beauty, the Norelco SensoTouch Electric Razor is featured at $89.99, almost $10 off the original price. This newly released razor features an ergonomic design, trimmer blade and cleaning brush. It is cordless and includes a stand, adaptor and protective cover.

Read: A Man’s Guide to a Great Shave

Also featured is the Oral-B Professional Care Toothbrush for $34.99. Oral-B calls electric toothbrushes a “wise choice”, as the vibration of the toothbrush head can provide extra cleaning action. Electric toothbrushes may also help improve brushing habits as many find them easier to use than manual toothbrushes.

Do you have allergies to pet dander or dust mites? Target has three Dyson vacuum cleaners on sale for Black Friday, including the DC17 All Floors Vacuum, the DC24 All Floors Vacuum and the DC25 Animal Vacuum. The latter, the most expensive of the three, has a HEPA filter and is certified as asthma and allergy friendly according to the Asthma and Allergy Foundation of America.

Read: Animal Lovers Overcome Pet Allergies With Environmental Control

Several sports and fitness products are on-sale to help increase physical activity by making it fun. Why not try a table tennis set with electronic scoring for $89.99? Ping-Pong, as it is more commonly called, is a great aerobic activity, beneficial for cardiovascular health. It can be enjoyed by everyone regardless of age or disability, and because you never play the same game twice, it eliminates the risk of boredom seen with many exercise activities.

According to clinical neuroscientist Dr. Daniel Amen, playing tabletop tennis is also good for the brain, increases hand-eye coordination, and has been shown to help children improve communication skills and develop self-esteem.

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Effective diagnosis, treatment of ear infections in children examined in study

Among the findings of an analysis of previous studies regarding ear infections in children are that results from otoscopic exams (an instrument for examining the interior of the ear) are critical to accurate diagnosis and antibiotics are modestly more effective than no treatment, with most antibiotics demonstrating similar rates of clinical success among children at normal risk, according to an article in the November 17 issue of JAMA. Acute otitis media (AOM; middle ear infection) is the most common childhood infection for which antibiotics are prescribed in the United States. A study using 2006 data indicated an average expenditure of $350 per child with AOM, totaling $2.8 billion. “Timely and accurate diagnosis and appropriate management of AOM may have significant consequences for ambulatory health care utilization and expenditures,” the authors write. “… however, wide variation exists in diagnosis and treatment.”

To examine recent trial results and changes in clinician practice, Tumaini R. Coker, M.D., M.B.A., of the David Geffen School of Medicine at UCLA, Los Angeles, and RAND, Santa Monica, Calif., and colleagues conducted a systematic review of relevant studies to support the new AOM practice guidelines (currently in preparation) from the American Academy of Pediatrics. The researchers examined the evidence for the precision and accuracy of AOM diagnosis; the association of heptavalent pneumococcal conjugate vaccine (PCV7) use with changes in AOM microbial epidemiology; and the decision about whether to treat with antibiotics, including the comparative effectiveness of different antibiotics and associated antibiotic-related adverse events. The authors identified 135 studies for inclusion in the review and analyzed those in which 3 or more articles examined the same comparison.

The researchers found that otoscopic findings of tympanic membrane bulging and redness were associated with accurate diagnosis. “Perhaps the most important way to improve diagnosis is to increase clinicians’ ability to recognize and rely on key otoscopic findings,” they write.

The authors also found that in the few available studies, prevalence of Streptococcus pneumoniae decreased (e.g., 33-48 percent vs. 23-31 percent of AOM isolates), while that of Haemophilus influenzae increased (41-43 percent vs. 56-57 percent) pre- vs. post-PCV7. Short-term clinical success was higher for immediate use of ampicillin or amoxicillin vs. placebo (73 percent vs. 60 percent), while increasing the rate of rash or diarrhea by 3 percent to 5 percent. Two of 4 studies showed greater clinical success for immediate vs. delayed antibiotics (95 percent vs. 80 percent and 86 percent vs. 70 percent).

“Of 100 average-risk children with AOM, approximately 80 would likely get better within about 3 days without antibiotics. If all were treated with immediate ampicillin/amoxicillin, an additional 12 would likely improve, but 3 to 10 children would develop rash and 5 to 10 would develop diarrhea. Clinicians need to weigh these risks (including possible long-term effects on antibiotic resistance) and benefits before prescribing immediate antibiotics for uncomplicated AOM,” they write.

The researchers add that data are absent on long-term effects on antimicrobial resistance. Meta-analyses in general showed no significant differences in antibiotic comparative effectiveness.

“We found evidence to guide the diagnosis and management of AOM in children; however, further research is needed that (1) examines clinicians’ diagnostic accuracy and precision using the 3 AOM diagnostic criteria [acute symptoms of infection, evidence of middle ear inflammation, and effusion]; (2) continues surveillance of AOM microbiology, especially in view of the newly approved PCV13; and (3) produces more high-quality studies on AOM management that include clear diagnostic criteria, a better-defined menu of clinical success measures that are universally applied, and more investigation into the comparative antibiotic-related adverse event rates that assesses whether any antibiotic regimen is superior to amoxicillin,” the authors conclude.

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