hafeezanwar
Junior Member
Obesity Drug Trials Fall Short of Meeting FDA Criteria
Being American, we want it all and we want it now. This is especially true for those who fall into the category of overweight or obese. Read any magazine, newspaper, or open any web page and the “guaranteed” weight loss products can be found in abundance.
These over-the-counter products do not have the testing and credentials behind prescription drugs, and pharmaceutical companies have been trying for years to provide an easy way to lose weight with prescription medications.
In the 1990s it seemed that Wyeth had found the answer with its popular “fen-phen” diet drugs, until it was found that they could cause heart damage and were removed from the market in 1997. The problems with “fen-phen” has made it necessary that all prescription medications being produced as a diet “pill” be studied carefully to make certain there is not a repeat of the heart damage problems seen with those drugs. Some other drugs that have been studied as diet aids have also produced psychiatric problems, but with over two thirds of the U.S. population considered overweight or obese a company that produced an effective, safe, weight control drug would have immense sales. So the search goes on.
Arena Pharmaceuticals just finished a late stage study of its drug lorcaserin. There were 3,182 patients involved in a two-year treatment plan. The drug did not cause heart valve damage or psychiatric side effects, but the weight loss was not as much as the company and its investors expected. Some analysts said that though the results did technically satisfy FDA requirements for proving the efficacy of the drug the weight loss results were not impressive.
Arena explained that lorcaserin stimulates a receptor in the brain that is thought to regulate food intake, without binding to similar receptors that cause heart problems. Among the study participants who took lorcaserin 47.5 percent lost at least 5 percent of their body weight after one year, compared to 20.3 percent of a placebo group. The weight loses results adjusted for placebo control is 3.6 percent which does not meet the FDA minimum required of 5 percent for approval. The company is optimistic that with the proven safety of the drug then can receive marketing approval from the agency in time. Arena said it will not seek FDA approval until after the completion of a second trial sometime around September. Even if Arena receives approval from the FDA the question is can they meet the approval of the marketplace with a weight loss percentage that could easily be attained with diet and life style changes?
There are three small California drug companies in the final stages of trying to find obesity treatments, Arena, based in San Diego, Orexigen Therapeutics, also of San Diego and Vivus, of Mountain View. Both Orexigen and Vivus have already presented late-stage clinical trials, but all three companies have other trials in progress. Because of safety concerns big drug companies Sanofi-Aventis, Merck, and Pfizer all discontinued work on obesity drugs last year because of concerns that the drugs, all with similar mechanisms could lead to depression and suicidal thoughts. With more failures than successes in the weight loss process easy weight loss is no closer than it has ever been. Those who seriously want to lose weight still have to depend on themselves to find their own weight loss program.
-----Agencies--
Being American, we want it all and we want it now. This is especially true for those who fall into the category of overweight or obese. Read any magazine, newspaper, or open any web page and the “guaranteed” weight loss products can be found in abundance.
These over-the-counter products do not have the testing and credentials behind prescription drugs, and pharmaceutical companies have been trying for years to provide an easy way to lose weight with prescription medications.
In the 1990s it seemed that Wyeth had found the answer with its popular “fen-phen” diet drugs, until it was found that they could cause heart damage and were removed from the market in 1997. The problems with “fen-phen” has made it necessary that all prescription medications being produced as a diet “pill” be studied carefully to make certain there is not a repeat of the heart damage problems seen with those drugs. Some other drugs that have been studied as diet aids have also produced psychiatric problems, but with over two thirds of the U.S. population considered overweight or obese a company that produced an effective, safe, weight control drug would have immense sales. So the search goes on.
Arena Pharmaceuticals just finished a late stage study of its drug lorcaserin. There were 3,182 patients involved in a two-year treatment plan. The drug did not cause heart valve damage or psychiatric side effects, but the weight loss was not as much as the company and its investors expected. Some analysts said that though the results did technically satisfy FDA requirements for proving the efficacy of the drug the weight loss results were not impressive.
Arena explained that lorcaserin stimulates a receptor in the brain that is thought to regulate food intake, without binding to similar receptors that cause heart problems. Among the study participants who took lorcaserin 47.5 percent lost at least 5 percent of their body weight after one year, compared to 20.3 percent of a placebo group. The weight loses results adjusted for placebo control is 3.6 percent which does not meet the FDA minimum required of 5 percent for approval. The company is optimistic that with the proven safety of the drug then can receive marketing approval from the agency in time. Arena said it will not seek FDA approval until after the completion of a second trial sometime around September. Even if Arena receives approval from the FDA the question is can they meet the approval of the marketplace with a weight loss percentage that could easily be attained with diet and life style changes?
There are three small California drug companies in the final stages of trying to find obesity treatments, Arena, based in San Diego, Orexigen Therapeutics, also of San Diego and Vivus, of Mountain View. Both Orexigen and Vivus have already presented late-stage clinical trials, but all three companies have other trials in progress. Because of safety concerns big drug companies Sanofi-Aventis, Merck, and Pfizer all discontinued work on obesity drugs last year because of concerns that the drugs, all with similar mechanisms could lead to depression and suicidal thoughts. With more failures than successes in the weight loss process easy weight loss is no closer than it has ever been. Those who seriously want to lose weight still have to depend on themselves to find their own weight loss program.
-----Agencies--