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 "Fen-Phen" 1997 was withdrawn from the market after it had come to an accumulation of valvular heart disease among users.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.
