BRIEF-Minerva Neurosciences Receives Complete Response Letter From FDA

Reuters02-27

Feb 27 (Reuters) - Minerva Neurosciences Inc :

* MINERVA NEUROSCIENCES RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR NEW DRUG APPLICATION FOR ROLUPERIDONE FOR THE TREATMENT OF NEGATIVE SYMPTOMS IN PATIENTS WITH SCHIZOPHRENIA

* MINERVA NEUROSCIENCES INC - WE BELIEVE THAT ROLUPERIDONE IS A SAFE AND EFFECTIVE THERAPY FOR NEGATIVE SYMPTOMS OF SCHIZOPHRENIA

* MINERVA NEUROSCIENCES INC - WILL REVIEW FDA'S FEEDBACK AND CONSIDER OUR POTENTIAL PATHS FORWARD

* MINERVA NEUROSCIENCES INC - IN CRL, FDA CITED NDA SUBMISSION LACKS DATA ON CONCOMITANT ANTIPSYCHOTIC ADMINISTRATION

* MINERVA-FDA CITED NDA SUBMISSION LACKS DATA TO ESTABLISH CHANGE IN NEGATIVE SYMPTOMS OF SCHIZOPHRENIA WITH ROLUPERIDONE TREATMENT CLINICALLY MEANINGFUL

* MINERVA-FDA CITED WHILE MIN-101C03 SHOWED SIGNIFICANCE ON MAIN EFFICACY GOAL, INSUFFICIENT ON ITS OWN TO ESTABLISH SUBSTANTIAL EFFECTIVENESS EVIDENCE

* MINERVA -FDA CITED SUBMITTED SAFETY DATABASE HAD INADEQUATE NUMBER OF SUBJECTS EXPOSED TO ROLUPERIDONE AT PROPOSED DOSE (64 MG) FOR AT LEAST 12 MONTHS

* MINERVA -FDA STATED CO MUST SUBMIT AT LEAST 1 ADDITIONAL POSITIVE, ADEQUATE, WELL-CONTROLLED STUDY TO SUPPORT SAFETY AND EFFECTIVENESS OF ROLUPERIDONE

* MINERVA NEUROSCIENCES - FDA ALSO PROVIDED COMMENTS ON, AMONG OTHER ITEMS, CLINICAL PHARMACOLOGY, PRODUCT QUALITY, BIOPHARMACEUTICS, NONCLINICAL ISSUES

* MINERVA NEUROSCIENCES - CO MUST PROVIDE ADDITIONAL DATA TO SHOW SAFETY AND EFFICACY OF ROLUPERIDONE CO-ADMINISTERED WITH ANTIPSYCHOTIC MEDICATIONS

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