Can new weight loss drugs rival Xenical

Recently, the American Food and Drug Administration (FDA), approved two new weight loss medications (Belviq and Qysmia), and America breathed a sigh of relief. While weight loss drugs have always been a topic of controversy, over the years it has become clear that their addition to the dieting efforts of many individuals, who struggle with obesity, is extremely beneficial. And with more than one third of Americans (35.7%) falling under the obese category, it is no surprise that medical alternatives to diet and exercise, are needed to counteract the issue.

New obesity treatments are needed to bridge the gap between diet and exercise and the more radical option of bariatric surgery. This is a view backed up by Dr Sue DeCotiis, New York City based Medical Internist and Weight Loss Management Specialist, who said, “While there are potential side effects with every medication, long term studies show that overweight patients do much better losing and keeping off weight, when they are prescribed a weight loss drug.”

“Weight loss medications work in conjunction with healthy eating and exercise, and offer individuals a chance at a real lifestyle change. Those who suffer from obesity often have a host of other health problems that come with the condition. These drugs can alleviate those symptoms, and the result is that many of these patients will live longer and avoid the consequences of medical problems, such as hypertension, stroke, and heart attack.”

Listed below is a description of current weight loss drugs and how they work. Previously the only option was Xenical, but now for the first time in 13 years, Doctors will have a choice of which weight loss drugs to prescribe to overweight or obese patients.

Belviq (Locaserin)

Approved by the FDA in late June of this year, this medication works by activating a receptor in the brain that helps a person to eat less and still feel full. By regulating the appetite, it lowers the likelihood of individuals overeating. It works best in patients who suffer from weight related conditions, such as high blood pressure, type 2 diabetes, or high cholesterol. At least 47.5% of patients lost at least 5% of their body weight from the medication, as opposed to 20.3% who took a placebo during a trial study period.

Qsymia (Phentermine & Topirmate)

This combination of the drugs Phentermine (an appetite suppressant and stimulant) and Topirmate (an anticonvulsant with weight loss side effects) is the most recent of the crop of weight loss medications, that have been approved by the FDA. Drugs in this category are primarily considered appetite suppressants. With the medication producing dramatic weight loss in patients, this is one of the clearest signs of hope for those suffering from obesity related diseases. About half of the patients lost 10% of their body weight and four-fifths lost 5%.

Contrave (Bupropion & Naltrexone)

This drug that is still to be approved by the FDA, works by combining two active ingredients that have been used for over twenty years. With Bupropion initiating the weight loss, Naltrexone sustains it by preventing the body’s natural tendency to counteract efforts, to lose weight. The result of this combination is to reduce appetite and increase the body’s metabolism, giving those who are suffering from obesity related illnesses the ability to sustain continued weight loss, by addressing the portion of the brain that controls food cravings.

Xenical (Orlistat)

Xenical, which is the most established and proven of the weight loss drugs, is a lipase inhibitor. Xenical does not enter the patient’s blood stream, but works in the digestive system in the small intestine as a fat absorber. It blocks out a third of the fat in food eaten in a patient’s diet, leading to steady weight loss. Research involving 11,131 woman and 4,418 men, who had been over weight for an average of 14 years, showed that 87% lost at least 5% of total body weight, half lost at least 10%, around 20% lost more than 15% body weight and some patients lost more than 25%.

Only time will tell which of these weight loss drugs is the most successful. Unfortunately here in the UK Belviq is not expected to be released until 2013 and there has been no UK release date as yet for Qsymia and Contrave. However all is not lost as here in the UK we still have Xenical available, which has a proven track record for assisting weight loss. Here at Medical Specialists Pharmacy we can dispense Xenical after an online consultation with one of our doctors and as soon as these other weight loss drugs become available, we will be offering them. Check our news section for further updates.

New drug Tudorza Pressair is given FDA backing for the treatment of COPD

This week has seen yet another new drug been given a clearance by The Food and Drug Administration (FDA), following the recent seal of approval for two new weight loss medications, Qsymia and Belviq, as we reported last week.

On this occasion, the drug to be given an authorisation for public use is a twice-daily inhaled medication named ‘Tudorza Pressair’, which is used to help treat symptoms of bronchospasm. This is associated with chronic obstructive pulmonary disease (COPD), aka ‘smoker’s cough’.

COPD is a term used for numerous conditions, including chronic bronchitis and emphysema, and is similar in certain characteristics to asthma. Bronchitis and emphysema are commonly co-existing diseases of the lungs in which the airways become narrowed, thus making it difficult for air to get in or out of the lungs.  Obvious symptoms can include chronic cough, tightness in the chest, and excessive phlegm.

Asthma and COPD can exist in the same person. However, in contrast to asthma, the inflammation of the lungs with COPD is not triggered by allergies and does not respond well to anti-inflammatory medication. In 2005, there were over 3 million deaths worldwide linked to COPD, with the main cause being the damaging effects of cigarette smoking.

On Tuesday, Spain’s biggest pharmaceutical company Almirall, and US drugmaker Forest Laboratories, confirmed they had been given the coveted FDA green light for Tudorza Pressair. This followed a slight hiccup back in March when the FDA demanded that it wanted a three-month extended time period to analyse the review data supporting the New Drug Application for aclidinium bromide (the powder ingredient within Tudorza Pressair).

Despite entering into an already competitive market where highly popular effective medications such as Ventolin can alleviate COPD symptoms, analysts at Sanford Bernstein say that sales of the Forest/Almirall drug could hit $164 million by 2015.

A spokesperson at Forest commented saying, “As the first long-acting inhaled anticholinergic agent approved in over 8 years for COPD, Tudorza will be an important treatment option.”
Curtis Rosebraugh, MD, Office of Drug Evaluation II, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland, said, “COPD is a serious disease that gets worse over time. The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease.”

However, the FDA have also warned that the drug may cause some serious side effects such as paradoxical bronchospasm, new or worsened urinary retention, or new or worsened pressure in the eyes (known as acute narrow-angle glaucoma). The FDA also says the medication is not fit to be used as a rescue therapy to help aid sudden breathing difficulties such as acute bronchospasm.

When Medical Specialists Pharmacy know more about this and other medications that are being approved by the FDA to help with asthma or COPD, we will update our patients immediately. In the meantime, Medical Specialists Pharmacy provides a huge range of medications to help asthma sufferers, all at great prices. If you have already been prescribed an inhaler, have lost your inhaler, or run out and cannot get a prescription immediately, we are able to supply you an inhaler to help your asthma symptoms.   After undergoing a private and confidential online consultation with one of our Doctors, if you are suitable they will then write you a prescription which is passed to our in-house Pharmacists and dispensed to a location of your choice. This is all done discretely and within just 24 hours. We offer both blue (relievers) inhalers such as Ventolin and Salbutamol, and brown (preventers) inhalers such as Qvar Beclomethasone, Qvar Easi-Breathe, and Pulvinal Beclomethasone.

Second new weight loss drug is given an FDA seal of approval

Vivus, Inc. has been given to go ahead to sell a new weight loss medication named ‘Qsymia’ by the US regulators The Food and Drug Administration (FDA). The approval from the FDA comes less than a month after delivering the same decision on another product for weight loss; Arena Pharmaceutical’s Belviq, which was given the go-ahead on June 27.

The dual approval by the FDA marks the first time a weight loss product has been certified fit for public use since 1999 when Roche were approved to sell ‘Xenical’. Some financial analysts now predict that Qsymia could generate an impressive $1.2 billion in sales by 2016.

The name Qsymia may be unfamiliar to most people as it was first manufactured under the name ‘Qnexa’, and declined by the FDA back in July of 2010 after they decided there were too many risks involved and that these were outweighing the benefits of the drug. Qsymia is an amalgamation of the appetite suppressant phentermine and the antiseizure drug topiramate.

The turnaround by the FDA on Qsymia may be partly due to Arena’s efforts to get their drug approved. In October 2010 the FDA declined Belviq and Arena set out to prove that the medication wasn’t as dangerous as the FDA believed it to be. Echocardiograms were carried out on almost 8,000 people to analyse heart-valve function. It was shown that there was no heart abnormalities present in the patient’s taking the medication and Arena have vowed to do six post-marketing studies which will include a long-term cardiovascular trial.

To demonstrate the safety of Qsymia, Vivus orchestrated two placebo-controlled trials spanning over a twelve month time period. The studies involved roughly 3,700 overweight and obese patients, some of whom had various health conditions that were linked to their weight. Subjects were instructed to make positive changes to their lifestyle and diet.

After the year had passed it was found that on average patients had experienced a weight loss of between 6.7% to 8.9%, depending on the dosage. It is expected that the recommended daily dose of Qsymia will 7.5 mg of phentermine and 46 mg of topiramate extended-release, with a higher dose of 15 mg phentermine and 92 mg of topiramate extended-release for certain patients.

However like all medications, some warnings will be issued in regards to who can and cannot take the drug. For starters, the FDA have made it clear that use of the medication will strictly be restricted to those with a body mass index (BMI) of 30 and above, or those with a BMI of 27 or more who also have a health condition that is linked to their weight. This could include high cholesterol, high blood pressure, or diabetes.

In addition, pregnant women will not be allowed to take the drug as there has been shown to be a huge risk to harm being caused to the foetus, such as a cleft lip forming or other problems. Patients with glaucoma or hyperthyroidism are also forbidden from taking the drug. As Qsymia can increase heart-rate, it is not advised for people to take it if they have heart disease or a stroke in the previous six months. The next stage for Vivus will be to perform further studies to thoroughly analyse what impact the drug has on cardiac health.

With the future releases of Belvic and Qsymia, these are clearly interesting times for the weight loss community. Furthermore, Californian biopharmaceutical company Orexigen Therapeutics, Inc., are currently undergoing clinical trials of its product, Contrave, targeting a 2014 FDA approval date. Keep checking the Medical Specialists Pharmacy website for all the latest news and information about the release dates of all three medications.