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KemPharm shared two developments involving their prodrug development pipeline for treatment of ADHD.
KemPharm (NASDAQ:KMPH) shared two developments involving their prodrug development pipeline for treatment of ADHD.
As quoted in the press release:
These advances include the development of a new prodrug product candidate of d-threo-methylphenidate (d-MPH), KP484, for ADHD indications that may benefit from a super-extended duration of treatment and the successful completion of an End-of-Phase 1 (EOP1) meeting with the U.S. Food and Drug Administration (FDA) for KP415.
“We now believe KemPharm’s ADHD prodrug portfolio is the company’s most valuable asset. In our view, the advances that we have made with KP415 and our newly developed product candidate for a super extended treatment, KP484, further support this belief,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We continue to view KP415 as our highest value product candidate, and we are excited to now take this prodrug to the next phase of its development. Since our quarterly update in May, we have initiated several pharmacokinetic studies of KP415 with data from these studies expected during the second half of 2017 and in early 2018. Now, following the End-of-Phase 1 meeting with the FDA, we are prepared to develop the commercial formulation of KP415 and initiate the pivotal efficacy study and human abuse liability program for KP415 in the second half of 2017; all pointing towards an NDA submission for KP415 as soon as late 2018.”
“The success of our KP415 program is now heightened by the development of a new product we are designating as KP484, which we are planning to develop for patients that require a product that provides a much longer duration of treatment for their ADHD,” Dr. Mickle continued. “In contrast to Shire’s recently approved amphetamine-based MYDAYISTM for extended duration of treatment for ADHD, initial clinical data on KP484 suggest our new methylphenidate product could offer substantially longer duration when compared to other methylphenidate ADHD drugs which is clearly an unmet need in treatment with methylphenidate. Given this, we have now activated the development program for KP484 with our first milestone being an IND filing in the third quarter.”
Click here to read the full press release.
Source: globenewswire.com
