| 2016-10-11 07:37:28|
KMPH 07:37 10/11 10/11/16
KemPharm receives FDA clearance to initiate KP415 clinical program
KemPharm announced that its Investigational New Drug, or IND, application for KP415 has been accepted by the FDA. KP415, KemPharm's co-lead product candidate, is an extended release d-threo-methylphenidate prodrug for the treatment of attention deficit hyperactivity disorder. KemPharm expects to commence and complete proof of concept human trials prior to the end of 2016, with additional human clinical trials initiating during the first half of 2017.