Rockville - This could be expanded in the coming months equal to three new drugs due to fatal risks in recent years to offer Abmagerungsmitteln thinned. Three companies have tried in the U.S. regulatory filings.
On 15 July involves an expert meeting of the FDA drug with the drug Qnexa from Vivus ®, a company in San Jose. It contains the active ingredients phentermine and topiramate. Phentermine is an appetite suppressant that promotes the release of norepinephrine in the hypothalamus, similar to a stress response dampens the appetite.
It has already been once marketed as an appetite suppressant and indeed as a component of "Fen-Phen." "Fen-Phen" 1997 was withdrawn from the market after it had come to an accumulation of valvular heart disease among users. These were later returned to the other component, fenfluramine, which promotes the release of serotonin, which induces a feeling of fullness. Phentermine is now regarded as safe. In Qnexa ® is combined with the antiepileptic drug topiramate, one of the known "side effects" of weight loss.
FDA reviewers to slimming Qnexa
Qnexa was reduced in two phase III trials in the highest dose, the body weight by 10.9 percent, 8.9 percent more than in the placebo arm. This is clear from the documents published in advance of the FDA. The stock market reacted with a rise in the share price of the manufacturer.
But the views of external experts do not necessarily coincide with the recommendations of analysts. A problem could be the known teratogenic side effects of topiramate, which occurred not only in animal experiments.
Patient registries have reported an increased rate of malformations in children of epileptic patients who were pregnant unintentionally. An FDA decision is expected in late October.
Previously, on 16 September should give their vote to FDA reviewers lorcaserin. Lorcaserin as fenfluramine increases the serotonin concentration. However, it binds selectively to the HT2C receptor subtype, which is not expressed on the heart valves. In previous clinical studies, it has not come to valvulopathy, as assured by the manufacturer Arena Pharmaceuticals of San Diego.
In the "Behavioral Modification and Lorcaserin for Overweight and Obesity Management" or the BLOOM study participants were obese (BMI 36) in the first year from an average of 5 percent, about 4 kg more than in the placebo arm.
In the second year, the gap narrowed to 2 kg, and participants who switched back to placebo in the second year, were at the other end as thick as participants who had received placebo the whole time. This is from the publication of the group headed by Steven Smith of the Sanford-Burnham Institute in Winter Park / Florida in the New England Journal of Medicine (2010, 363: 245-256) show.
Relevant to the FDA, however, should not be the extent of the effect, but the certainty that no harm can be expected in the heart valves or elsewhere.
The third new drug is the Contrave ®. It contains the active ingredients naltrexone and bupropion. Naltrexone is an opioid antagonist that is used to support drug withdrawal treatment in opiate and alcohol addicts. Bupropion is approved for the treatment of depression.
Contrave is the "craving" So that seeks to prevent food-like. In the studies, there was a weight loss of about 10 percent. The therapy was not without side effects: one in three patients reported nausea and one quarter it came to constipation. Both should promote not just the willingness of obese people to take their medication. The experts meeting of the FDA is for the 7th Scheduled in December.
All manufacturers should in case of an approval to carry out further studies will be made compulsory. This is evident not least from the experience of recent years. Three years ago, had the cannabinoid receptor antagonist rimonabant in Europe are taken because of an increased rate of depression and suicidal thoughts from the market.
Only in January this year was in Europe suspended the approval of sibutramine, after it had come in a larger study to an increase in cardiovascular events.
Saturday 3 December 2011
FDA: Three diet pills in a month denied admission
Rockville - After sibutramine, which was in the U.S. until the beginning of the month has pushed the market, the U.S. Pharmacopoeia Drug Administration two other diet pills issued a denial: lorcaserin and the combination of Diphentermin / topiramate, the license was denied.
Early October, as reported by the manufacturer Abbott Meridia ® (active ingredient: Sibutramine) in North America and Australia voluntarily from the market. He came to a ban by the FDA before. The European Pharmacopoeia Authority EMA had been suspended in January 2010, the approval of Reductil ® with the same active ingredient.
The cause was the small effect of sibutramine coupled with an increase of cardiovascular complications in "Sibutramine Cardiovascular Outcomes Trial" (SCOUT). The patients lost less than 5 percent of body weight, and then also affected more often from heart attacks or stroke, which should protect against a medically indicated diet pill really.
On 23 October was then Arena Pharmaceuticals of San Diego Post by the FDA.The authorities complained that the reduction of excess weight had broken down in non-diabetic people with overweight or obesity only marginally.
In addition, the final results of "behavioral modification and lorcaserin for Overweight and Obesity Management in Diabetes Mellitus" or lay BLOOM-DM trial in diabetic patients not yet available. The study was completed in May 2010. A publication is pending. The manufacturer announced it now for the next few weeks.
The primary endpoint was a reduction in body weight by 5 percent, which the FDA has set as a condition of approval. For the medical benefits but should also be the results in the secondary endpoints of the influence on HbA1c, blood pressure and lipid metabolism is important.
Valvular heart disease among lorcaserin: diet pill lowers HbA1c
The FDA is also concerned about a possible cancer risk: In preclinical experiments, it was in female rats had increased to breast cancer - humans certainly no unacceptable adverse effect of diet pill.
Even with the third drug safety concerns are paramount. The FDA refused on 28October 2010, the approval of Qnexa ® by Vivus in Mountain View / California off, although the two drugs in the United States has long been on the market.
Phentermine was approved in 1959 by the FDA as an appetite suppressant. It is even touted as a generic. In the 90s there was a component of "Fen-Phen", which was banned because of an increased rate of heart valve defects. This complication, however, was the fenfluramine ("fen") attributed. Phentermine ("phen") was classified as harmless.
The second component of Qnexa is the anti-epileptic drug topiramate, which triggers a side effect of weight loss. As a combination of phentermine and topiramate are about twice as effective as sibutramine or lorcaserin. The participants in the clinical studies, an average of 10 percent of body weight.
Both agents have side effects: Phentermine increases heart rate, topiramate can interfere with concentration and memory, increase the risk of suicide and induce a metabolic acidosis and kidney stones. It is also suspected to be teratogenic.
This may be tolerable when used as anti-epileptic drug. With a diet pill that fell so much weight that the external reviewers of the FDA in July 2010 with 10 votes to 6 against the admission uttered. The FDA has now joined this vote.
After three years of Acomplia ® (active ingredient rimonabant) has been taken due to an increased risk of suicide from the market, is currently only with the active ingredient orlistat, Xenical ® on the market. It inhibits the breakdown of fats in the intestine and thus their absorption, but this can lead to the patient unpleasant greasy stools (steatorrhea).
For December 2010, the FDA has scheduled an advisory meeting on Contrave ®, a combination of bupropion and naltrexone. Should not this drug will be approved, the manufacturer should slow the interest in developing lose from diet pills - and leave the market to the illegal suppliers of products containing the banned drugs such as sibutramine, which in recent months repeatedly offered in the Internet and from theauthorities had to be confiscated.
Early October, as reported by the manufacturer Abbott Meridia ® (active ingredient: Sibutramine) in North America and Australia voluntarily from the market. He came to a ban by the FDA before. The European Pharmacopoeia Authority EMA had been suspended in January 2010, the approval of Reductil ® with the same active ingredient.
The cause was the small effect of sibutramine coupled with an increase of cardiovascular complications in "Sibutramine Cardiovascular Outcomes Trial" (SCOUT). The patients lost less than 5 percent of body weight, and then also affected more often from heart attacks or stroke, which should protect against a medically indicated diet pill really.
On 23 October was then Arena Pharmaceuticals of San Diego Post by the FDA.The authorities complained that the reduction of excess weight had broken down in non-diabetic people with overweight or obesity only marginally.
In addition, the final results of "behavioral modification and lorcaserin for Overweight and Obesity Management in Diabetes Mellitus" or lay BLOOM-DM trial in diabetic patients not yet available. The study was completed in May 2010. A publication is pending. The manufacturer announced it now for the next few weeks.
The primary endpoint was a reduction in body weight by 5 percent, which the FDA has set as a condition of approval. For the medical benefits but should also be the results in the secondary endpoints of the influence on HbA1c, blood pressure and lipid metabolism is important.
Valvular heart disease among lorcaserin: diet pill lowers HbA1c
The FDA is also concerned about a possible cancer risk: In preclinical experiments, it was in female rats had increased to breast cancer - humans certainly no unacceptable adverse effect of diet pill.
Even with the third drug safety concerns are paramount. The FDA refused on 28October 2010, the approval of Qnexa ® by Vivus in Mountain View / California off, although the two drugs in the United States has long been on the market.
Phentermine was approved in 1959 by the FDA as an appetite suppressant. It is even touted as a generic. In the 90s there was a component of "Fen-Phen", which was banned because of an increased rate of heart valve defects. This complication, however, was the fenfluramine ("fen") attributed. Phentermine ("phen") was classified as harmless.
The second component of Qnexa is the anti-epileptic drug topiramate, which triggers a side effect of weight loss. As a combination of phentermine and topiramate are about twice as effective as sibutramine or lorcaserin. The participants in the clinical studies, an average of 10 percent of body weight.
Both agents have side effects: Phentermine increases heart rate, topiramate can interfere with concentration and memory, increase the risk of suicide and induce a metabolic acidosis and kidney stones. It is also suspected to be teratogenic.
This may be tolerable when used as anti-epileptic drug. With a diet pill that fell so much weight that the external reviewers of the FDA in July 2010 with 10 votes to 6 against the admission uttered. The FDA has now joined this vote.
After three years of Acomplia ® (active ingredient rimonabant) has been taken due to an increased risk of suicide from the market, is currently only with the active ingredient orlistat, Xenical ® on the market. It inhibits the breakdown of fats in the intestine and thus their absorption, but this can lead to the patient unpleasant greasy stools (steatorrhea).
For December 2010, the FDA has scheduled an advisory meeting on Contrave ®, a combination of bupropion and naltrexone. Should not this drug will be approved, the manufacturer should slow the interest in developing lose from diet pills - and leave the market to the illegal suppliers of products containing the banned drugs such as sibutramine, which in recent months repeatedly offered in the Internet and from theauthorities had to be confiscated.
FDA reviewers to slimming Qnexa
Washington - The external reviewers of the U.S. Pharmacopoeia Drug Administration rejected the approval of Qnexa ® slimming majority. The safety concerns are greater than the benefits of the drug, which combines the active ingredients phentermine and topiramate.
Phentermine and topiramate have been approved in the U.S.. Phentermine was part of the popular slimming "fen-phen," which had to be taken off the market in 1997 because of other "fen-phen" drug fenfluramine may damage the heart valves. Topiramate is a proven anti-epileptic drug, one of whose side effects include weight loss.
On the efficacy of Qnexa, the experts had no doubts. It fell in the Phase III trials, the body weight by about 10 percent. But even if the two drugs are approved, this does not a priori safety concerns.
The FDA staff had called in advance several problems: increased heart rate phentermine, topiramate can interfere with concentration and memory, increase the risk of suicide and induce a metabolic acidosis and kidney stones. It is also suspected to be teratogenic.
These risks weighed for 10 experts more than the benefits of the drug, while six experts spoke out for approval. The FDA is not bound by the vote, and observers, it appears not impossible that it flouts the authority itself.
The decision will be announced in October. In September, the evaluators will have to vote on the antiobesity lorcaserin. For December, a meeting is scheduled for Contrave ®, which combines the active ingredients bupropion and naltrexone.
Phentermine and topiramate have been approved in the U.S.. Phentermine was part of the popular slimming "fen-phen," which had to be taken off the market in 1997 because of other "fen-phen" drug fenfluramine may damage the heart valves. Topiramate is a proven anti-epileptic drug, one of whose side effects include weight loss.
On the efficacy of Qnexa, the experts had no doubts. It fell in the Phase III trials, the body weight by about 10 percent. But even if the two drugs are approved, this does not a priori safety concerns.
The FDA staff had called in advance several problems: increased heart rate phentermine, topiramate can interfere with concentration and memory, increase the risk of suicide and induce a metabolic acidosis and kidney stones. It is also suspected to be teratogenic.
These risks weighed for 10 experts more than the benefits of the drug, while six experts spoke out for approval. The FDA is not bound by the vote, and observers, it appears not impossible that it flouts the authority itself.
The decision will be announced in October. In September, the evaluators will have to vote on the antiobesity lorcaserin. For December, a meeting is scheduled for Contrave ®, which combines the active ingredients bupropion and naltrexone.
Saturday 19 November 2011
about phentermine pills
Information about about phentermine pills and medication for weight loss. Be patient, while we compile it for you.
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