Three new weight loss drugs could soon win FDA approval

[black7]

Three new weight loss drugs could soon win FDA approval


(NBC) - Three new weight loss drugs could soon be approved to help treat the more than 200-million Americans considered overweight or obese.

There's no magic pill that will melt away fat. Hard work is involved: Exercise, eating right, more exercise and more eating right. However, when you hit that weight-loss plateau, drug companies are lined up to step in.

First on the list for consideration by the Food and Drug Administration is a pill called Qnexa. It's a combination of two appetite suppressants, including one called Phentermine.

Phentermine is considered safe, but was part of the notorious Fen-Phen that was taken off the market years ago after it was linked to heart valve problems.

Another experimental drug called Lorcaserin had very few side effects in clinical trials where patients lost an average of 17 pounds over a year. Patients were slimmer, and researchers say, healthier.

"Things like blood pressure, blood sugar, inflammation, all of these markers improved in the Lorcaserin studies," said Dr. Louis Aronne of the Weill Cornell Medical Center.

Lorcaserin could be recommended for approval sometime this fall.

In December FDA advisors are scheduled to review another weight loss drug called Contrave. It is a combination of an anti-depressant and another drug used for alcohol addiction.

While they might all work, none of these new drugs will be as effective without the old advice: Eat a healthy diet and get plenty of exercise.

If approved, Qnexa would be the first new prescription weight-loss drug in a decade.

 

[liftsiron]

May be some merit to this:
Qnexa?, produced by Vivus Inc, is a medication being studied for the treatment of obesity. Qnexa is an appetite suppressant and is a blend of two separate already existing medications Phentermine and Topiramate (brand name Topamax?). Phentermine has been approved by the FDA and has been used for many years as a very successful weight loss formula. Topiramate is a medication that has also been approved by the FDA and has been used for years as an anticonvulsant to treat epilepsy and has also been used to treat migraine headaches or as an antidepressant. However, it is the combination that is being tested and the results are promising.
It is believed that Qnexa will greater reduce appetite and increase weight loss than Phentermine or Topiramate alone as well as show that it is a safer drug than either one substance by itself. Studies have shown that Qnexa has attained a larger weight loss compared to the placebo as well as compared to each of the two combined drugs individually. The FDA requires that in order for an obesity drug to be considered effective it must show that at least a third of the test patients lose at least 5% of their body weight. Qnexa passed this better than most.

 

[black7]

The combination of the drugs phentermine and topiramate (trade name Qnexa) is an investigational medication for the treatment of obesity and related conditions such as type 2 diabetes and has been found to lower blood pressure and cholesterol.[1] Qnexa is being developed by Vivus, Inc. (NASDAQ: VVUS ), a California pharmaceutical company.[2] Phentermine is an appetite suppressant and stimulant of the amphetamine and phenethylamine class. Topiramate is an anticonvulsant that has weight loss side effects.

Clinical studies have shown weight loss under treatment with Qnexa. The phase 3, 56-week EQUIP study showed that the average weight loss of 14.7% (37 lbs) was achieved by obese patients treated with Qnexa.[3] The following doses of Phentermine IR and Topiramate CR where used in Phase 3 testing:

* Full strength formula: 15 mg of Phentermine IR and 92 mg of Topiramate CR
* Mid strength formula: 7.5 mg Phentermine IR and 46 mg Topiramate CR
* Low strength formula: 3.75 mg Phentermine IR and 23 mg Topiramate CR

The main side effects reported during testing phases where: dry mouth, a tingling in the fingers and toes, and constipation.[4] On December 28, 2009 a new drug application (NDA) was submitted to the FDA for approval[5] and on March 1, 2010, Vivus announced that the agency accepted the NDA.[6]

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee reviewed Qnexa on July 15, 2010. The committee voted narrowly against recommending approval.[7] The FDA will take the Committee's recommendation into consideration during its review of the Qnexa NDA and will make a determination. The FDA may or may not follow the Committee's recommendation.

The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.[8]

Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea (OSA). A phase 2 safety and efficacy study evaluating Qnexa in patients with OSA showed that patients who took Qnexa had a 69 percent reduction in sleep apnea events and lost more weight than those who took placebo.[9]

Vivus currently has four U.S. patents covering Qnexa. These patents are related to the product and methods of using the drug in various therapeutic applications.[10]

Further research data released indicates that Qnexa lowers blood pressure. Dr. Suzanne Oparil of the Univesity of Alabama at Birminham stated “The higher the dose, the more weight loss and the more blood pressure went down” presented at the American Society of Hypertension’s 25th annual meeting in New York.[11]

 

[black7]

it should be noted that these appetite suppressants are IMO only for the obese... I honestly dont think to would help people that are trying to cut down who are already in good shape. Appetite suppressants do exactly what they saw, suppress appetite. Its mostly geared toward people who over eat.

If you already have a good balanced diet and eat proper proportions these drugs are not for you.

 

[black7]

Talk about a stock to buy!!! the last sale price for Vivius was $ 4.7701..... if this gets FDA approval in October and sells at an alarming rate you can increase profits up to 250%...

 

[black7]

i think i am going to invest...

 

[Thate]

If you already have a good balanced diet and eat proper proportions these drugs are not for you.

I don't know bro, phentermine was like suped up ephedrine

 

[theartofwar]

ditto on phentermine - that shit was rocket fuel