Press "Enter" to skip to content

Announced today that it offers resubmitted its AZ-004 New Medication Software to the U.

Alexza resubmits AZ-004 NDA for treatment of agitation in schizophrenia patients Alexza Pharmaceuticals, Inc. announced today that it offers resubmitted its AZ-004 New Medication Software to the U.S. Food and Medication Administration in response to a Complete Response Letter received in October 2010. As well as the data from the initial NDA and extra analyses of some of those data, the AZ-004 resubmission contains brand-new data from the effectively completed human factors study, stability data from fresh production batches manufactured late last year, updated manufacturing and settings sections addressing results from the Company’s Pre-Acceptance Inspection, and up to date draft labeling and a thorough REMS proposal..Related StoriesEndocrine Culture problems Clinical Practice Guideline on treatment of menopausal symptomsResearch examines ramifications of antidepressant make use of on health of mom and childKey neurotransmitter receptor may be a potential focus on for individualised Autism Spectrum Disorder treatment’We have used what is known as neuroendocrine ways to show that it’s principally the serotonergic program in the brain that is seriously impaired by alcohol. This is the operational system that regulates impulse control and mood, among other features’, says Kristina Berglund, scientist at the Department of Psychology and representative for the study group. Men and women suffer adverse effects, however the effects arise a lot more in women rapidly. The results show that the function of women’s serotonin program has fallen by 50 percent after as little as four years with problematic alcohol consumption, while it will take 12 years before the function of men’s systems is normally halved.