Alexza resubmits ADASUVE NDA to U.

Alexza resubmits ADASUVE NDA to U.S. FDA Alexza Pharmaceuticals, Inc. announced today that it offers resubmitted its ADASUVE New Medication Program to the U.S. Food and Drug Administration in response to a Comprehensive Response Letter received in May 2012. ADASUVE NDA Regulatory Upgrade IN-MAY 2012, Alexza received a CRL from the FDA. The Might 2012 CRL also included feedback on Alexza’s draft item labeling. Related StoriesNew analysis finds illogical thoughts as most predictive of schizophrenia riskNovel research tool identifies link between unfavorable symptoms of schizophrenia and adverse medical outcomesVraylar capsules right now approved by FDA to treat schizophrenia, bipolar disorder in adultsThere had been no fresh clinical or safety problems identified and there have been no various other deficiencies outlined in the CRL.Efficacy A significantly greater %age of sufferers receiving active treatment than those receiving placebo met the criteria for an ACR 20 response at month 6: 51.5 percent in the 5-mg tofacitinib group, 52.6 percent in the 10-mg tofacitinib group, and 47.2 percent in the 40-mg adalimumab group, as compared with 28.3 percent in the placebo group . The mean change from baseline in the HAQ-DI rating at month 3 and the %age of sufferers with a DAS28-4 below 2.6 at month 6 had been also significantly better with the active treatments than with placebo.05 for all comparisons). The magnitude of these responses was sustained to month 12 and was numerically very similar among the three active-treatment groups .001 for all comparisons) .