KemPharm Presents Poster at ACNP’s 57th Annual Meeting Highlighting the Intravenous Abuse Potential of Serdexmethylphenidat...
December 12 2018 - 7:30AM
Findings suggest that SDX, a prodrug of
d-methylphenidate, is unlikely to be attractive for intravenous
abuse
KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company
engaged in the discovery and development of proprietary prodrugs,
today announced that research assessing the intravenous (IV) abuse
potential of serdexmethylphenidate (SDX), KemPharm’s prodrug of
d-methylphenidate (d-MPH), will be presented by Megan Shram, Ph.D.,
at the 57th Annual Meeting of the American College of
Neuropsychopharmacology (ACNP). SDX is the major active
pharmaceutical ingredient in KP415 and KP484, KemPharm’s co-lead
clinical development product candidates intended for the treatment
of attention-deficit/hyperactivity disorder (ADHD), as well as
KP879, a newly developed product candidate designed for the
treatment of Stimulant Use Disorder (SUD).
The poster, titled, “Assessment of the
Intravenous Abuse Potential Of Serdexmethylphenidate (SDX), a
Novel, Investigational Prodrug of D-Methylphenidate: Evidence from
Nonclinical and Clinical Studies,” highlighted a series of in vitro
and in vivo studies designed to examine the IV abuse potential of
SDX. Of importance:
- SDX, as the intact prodrug, had no discernible pharmacologic
activity and was not readily converted to d-MPH in human whole
blood, plasma, and liver fractions
- IV administration of SDX to rats and humans yielded very low
systemic exposure to d-MPH
- IV administration of SDX to recreational stimulant abusers
produced pharmacodynamic effects that were comparable to placebo
and significantly lower than IV d-MPH HCl (at an equimolar dose) on
multiple abuse-related endpoints
“The data presented at ACNP demonstrate that
SDX, KemPharm’s prodrug of d-methylphenidate, possesses unique
properties that may significantly limit its abuse potential when
administered intravenously,” said Dr. Shram, Director at Altreos
Research Partners and Adjunct Professor of Pharmacology at the
University of Toronto. Dr. Shram is the lead author for the
poster and will present the data to the ACNP Annual Meeting
attendees.
“These results provide an important snapshot of
the KP415 Human Abuse Potential (HAP) program, which suggested that
SDX, the major active pharmaceutical ingredient of KP415, has lower
abuse potential than relevant d-MPH comparators when administered
intravenously, intranasally, or orally at high doses,” said Travis
Mickle, Ph.D., President and Chief Executive Officer of KemPharm.
“The ability to limit abuse potential is a key element to the value
proposition of KP415, and we appreciate Dr. Shram’s presentation of
these findings to the ACNP Annual Meeting attendees. We
remain on track to submit our New Drug Application for KP415 with
the FDA as early as Q1 2019.”
KemPharm funded the study which was conducted by
Altreos Research Partners.
About KemPharm:
KemPharm is a specialty pharmaceutical company
focused on the discovery and development of proprietary prodrugs to
treat serious medical conditions through its proprietary LATTM
(Ligand Activated Therapy) technology. KemPharm utilizes its
proprietary LAT technology to generate improved prodrug versions of
FDA-approved drugs as well as to generate prodrug versions of
existing compounds that may have applications for new disease
indications. KemPharm’s product pipeline is focused on the
high need areas of ADHD, pain, and other central nervous system
disorders. Its co-lead clinical development candidates are
KP415 and KP484, both based on a prodrug of d-methylphenidate, but
with differing extended-duration profiles intended for the
treatment of ADHD. In addition, KemPharm has received FDA
approval for APADAZ®, an immediate-release combination product
containing benzhydrocodone, a prodrug of hydrocodone, and
acetaminophen. For more information on KemPharm and its
pipeline of prodrug product candidates visit www.kempharm.com or
connect with us on Twitter, LinkedIn, Facebook and YouTube.
About the ACNP:
The American College of Neuropsychopharmacology,
ACNP, founded in 1961, is a professional organization of more than
1,100 leading scientists, including four Nobel Laureates. The
mission of ACNP is to further research and education in
neuropsychopharmacology and related fields in the following ways:
promoting the interaction of a broad range of scientific
disciplines of brain and behavior in order to advance the
understanding of prevention and treatment of disease of the nervous
system including psychiatric, neurological, behavioral and
addictive disorders; encouraging scientists to enter research
careers in fields related to these disorders and their treatment;
and ensuring the dissemination of relevant scientific advances.
Caution Concerning Forward Looking
Statements:
This press release may contain forward-looking
statements made in reliance upon the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements include all statements that do not
relate solely to historical or current facts, and can be identified
by the use of words such as “may,” “will,” “expect,” “project,”
“estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,”
“continue” or the negative versions of those words or other
comparable words. Forward-looking statements are not guarantees of
future actions or performance. These forward-looking statements are
based on information currently available to KemPharm and its
current plans or expectations and are subject to a number of
uncertainties and risks that could significantly affect current
plans. Risks concerning KemPharm’s business are described in detail
in KemPharm’s Annual Report on Form 10-K for the year ended
December 31, 2017, and KemPharm’s other Periodic and Current
Reports filed with the Securities and Exchange Commission.
KemPharm is under no obligation to (and expressly disclaims any
such obligation to) update or alter its forward-looking statements,
whether as a result of new information, future events or
otherwise.
Investor/Media Contacts: |
Jason
Rando / Joshua Drumm, Ph.D.Tiberend Strategic Advisors,
Inc.212-375-2665 / 2664jrando@tiberend.comjdrumm@tiberend.com |
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