January 19th FDA plans to approval of diet drug Acomplia (rimonabant) Zimulti name in USA
Merck reiterated on January. 19th that it plans to file for FDA approval of diet drug Acomplia (rimonabant) “Taranabant” in 2008 even though some adverse psychiatric side-effects have been observed similar to those found with Sanofi’s diet drug Acomplia (rimonabant).
Taranabant, a CB-1 receptor inverse agonist, and Acomplia (rimonabant) , a CB-1 receptor antagonist, are in the same class of drugs which operate by blocking receptors in the brain and other organs that when activated by marijuana make pot smokers feel hungry when you receive the drug Acomplia (rimonabant).
While Acomplia (rimonabant) was approved for sale in Europe where it is marketed as Acomplia (Rimonabant first name later, Zimulti brend name in USA)., an FDA advisory panel earlier this year overwhelmingly recommended that Acomplia (rimonabant) it not be approved in the U.S., where it was to be marketed as Zimulti, expressing concern over lack of data on psychiatric side effects, despite the fact that there is a clear positive results during a reception drug Acomplia ( Zimulti)
Sanofi subsequently withdrew the FDA application for Rimonabant , but has indicated it intends to refile when it has more data.
Now Merck says that its diet drug, which is nearing the end of phase III trials, has shown that like Acomplia it can help overweight and obese people lose weight, but conceded that researchers also have observed psychiatric side effects while taking pills Acomplia ( Zimulti) .
“ We also observed a dose-dependent increase in psychiatric adverse experiences, which we think are mechanism-based,” Peter Kim, Merck’s president of research, told investors.
In an effort to minimize problems, Merck is studying a 4 mg dose and a 6 mg dose of taranabant in its phase III clinical trial. While Sanofi tested a 5 mg dose of Acomplia (rimonabant) , results at that dosage were disappointing and it ultimately settled on the 20 mg dose being sold in Europe and some other countries.
Merck also is including people with controlled depression in its clinical trials unlike Sanofi, which excluded those with a history of depression.
Метки:20 mg, clinical, diet drug, dosage, drug, Europe, fda, lose weight, obese, results, side effects, study, usa, weight, Zimulti
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