KemPharm Announces Research Involving AZSTARYS® and Serdexmethylphenidate to be Featured in Poster Presentations at Multiple Medical Conferences during ADHD Awareness Month (October)
20 October 2021 - 10:30PM
KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical
company focused on the discovery and development of proprietary
prodrugs, today announced that research involving AZSTARYS®
and serdexmethylphenidate (SDX), the company’s proprietary prodrug
of d-methylphenidate (d-MPH), will be featured in poster
presentations during multiple medical conferences being held in
October (ADHD Awareness Month). Presentations will be given at the
following conferences:
Event: |
American Academy of Child & Adolescent Psychiatry 68th Annual
Meeting (AACAP 2021) |
Date: |
October 18-30, 2021 |
Title: |
Single-Dose Pharmacokinetics of
Serdexmethylphenidate/d-Methylphenidate Capsules in Children and
Adolescents with ADHD and Healthy Adults: An Evaluation of Age and
Body Weight |
Event: |
Psych Congress |
Date: |
October 29-November 1, 2021 |
Title: |
Steady-State Pharmacokinetics and Relative Bioavailability of
Serdexmethylphenidate/d-Methylphenidate, a Treatment for
Attention-Deficit/Hyperactivity Disorder, Containing a Novel
Prodrug of d-Methylphenidate |
During AACAP 2021, Rene A. Braeckman, Ph.D.,
Vice President, Clinical Development for KemPharm, will present the
poster titled, “Single-Dose Pharmacokinetics of
Serdexmethylphenidate/d-Methylphenidate Capsules in Children and
Adolescents with ADHD and Healthy Adults: An Evaluation of Age and
Body Weight,” which highlights data from two Phase 1 clinical
trials evaluating the pharmacokinetic (PK) properties of single
doses of AZSTARYS administered to children, adolescents, and
adults. Researchers demonstrated that the shape of the PK curves in
children and adolescents was similar to that in adults. Consistent
with published studies of methylphenidate PK, exposure of d-MPH
decreased with age due to body weight differences between younger
children and adolescents. However, when normalized by dose and body
weight, d-MPH exposure levels and PK parameters were comparable
between children, adolescents, and adults. Researchers concluded
that body weight rather than age is the appropriate scaling factor
for d-MPH exposure levels after AZSTARYS dosing in children and
adolescents.
“We are pleased that clinical research involving
AZSTARYS and SDX have been accepted for poster presentations during
multiple medical conferences in October, coinciding with ADHD
Awareness Month,” said Travis Mickle, Ph.D., President and CEO of
KemPharm. “Our goal in developing AZSTARYS was to advance the
treatment of ADHD by bringing to market a product that could
address several key shortcomings of other commercially available
ADHD drugs. The data being presented at these conferences
highlights several properties of AZSTARYS and SDX that, we believe,
will be attractive to patients and prescribers who have been
seeking innovative therapies that address the symptoms of ADHD,
while also reducing the side-effects sometimes encountered with
stimulant-based medications.”
About Attention Deficit Hyperactivity
Disorder (ADHD):
Attention-deficit/hyperactivity disorder (ADHD)
is one of the most common mental disorders affecting children. ADHD
also affects many adults. Symptoms of ADHD include inattention (not
being able to keep focus), hyperactivity (excess movement that is
not fitting to the setting) and impulsivity (hasty acts that occur
in the moment without thought).1 An estimated 8.4% of children and
2.5% of adults have ADHD.23
The U.S. ADHD market accounted for
approximately $17.5 billion of revenue in 2019 with a
year-over-year prescription growth rate greater than four percent
(4%). Within this, the branded portion of the ADHD market was
approximately $7.4 billion in 2019, with extended-release
products representing more than 95% of the branded
prescriptions. In 2019, the methylphenidate segment of
the ADHD market accounted for approximately 20 million
prescriptions and $4.9 billion in sales.
About
AZSTARYS®:
AZSTARYS is an FDA-approved, once-daily product
for the treatment of attention deficit hyperactivity disorder
(ADHD) in patients age six years or older. AZSTARYS consists of
SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated
with immediate release d-MPH.
The complete approved prescribing information
for AZSTARYS may be downloaded in PDF format
here:https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label-Final_20210302.pdf
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 LAT®
(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 prodrug product candidate pipeline is
focused on the high need areas of attention deficit hyperactivity
disorder, or ADHD, stimulant use disorder (SUD) and CNS rare
diseases, including idiopathic hypersomnia (IH). KemPharm’s lead
clinical development candidate for the treatment of SUD, KP879, is
based on its prodrug of d-methylphenidate, known as
serdexmethylphenidate (SDX). In addition, KemPharm has received FDA
approval for AZSTARYS®, a new once-daily treatment for ADHD in
patents age six years and older, and 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.
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 Quarterly Report on Form 10-Q for the quarter ended
June 30, 2021, and KemPharm’s other filings 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.
KemPharm Contacts:
Tiberend Strategic Advisors, Inc.Jason
Rando/Maureen McEnroe, CFA(212) 375-2665 /
2664jrando@tiberend.commmcenroe@tiberend.com
____________________________
1 American Psychiatric Association
(https://www.psychiatry.org/patients-families/adhd/what-is-adhd) 2
Danielson, ML, et al. Prevalence of Parent-Reported ADHD
Diagnosis and Associated Treatment Among U.S. Children and
Adolescents, 2016. Journal of Clinical Child & Adolescent
Psychology, Volume 47, 2018 - Issue 23 Simon V ,
Czobor P, Bálint S , et al: :Prevalence and
correlates of adult attention-deficit hyperactivity
disorder: a meta-analysis. Br J
Psychiatry194(3):204–211, 2009
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