KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical
company focused on the discovery and development of proprietary
prodrugs, today announced that research involving AZSTARYS® is
being featured in a poster presentation during the 2021 Psych
Congress being held both virtually and in-person in San Antonio,
Texas, from October 29 through November 1, 2021. The presentation
highlights data from clinical studies assessing the relative
bioavailability and the steady-state pharmacokinetics (PK) of
AZSTARYS.
AZSTARYS is a once-daily product for the
treatment of ADHD in patients aged six years and older consisting
of serdexmethylphenidate (SDX), KemPharm’s prodrug of
d-methylphenidate (d-MPH), co-formulated with immediate-release
d-MPH. Corium, Inc. (Corium), a portfolio company of Gurnet Point
Capital (GPC), is commercializing AZSTARYS in the U.S.
The poster, titled, “Steady-State
Pharmacokinetics and Relative Bioavailability of
Serdexmethylphenidate/d-Methylphenidate, a Treatment for
Attention-Deficit/Hyperactivity Disorder, Containing a Novel
Prodrug of d-Methylphenidate,” detailed data from two separate
pharmacokinetic studies. The first study compared the amount of
d-MPH that reached systemic circulation (relative bioavailability)
in 30 patients administered a single dose of AZSTARYS and a single
dose of extended-release d-MPH hydrochloride (HCI). Data in the
poster revealed that following a single dose of AZSTARYS (SDX/d-MPH
capsules), d-MPH plasma concentrations increased rapidly and were
sustained through late-day time points. This extended-duration
exposure profile is governed by the unique properties of the
prodrug, SDX, which is gradually converted to active d-MPH after
reaching the intestinal tract.
The second study in the poster presentation
highlighted data demonstrating that AZSTARYS administered once
daily over a four-day period achieved steady-state d-MPH plasma
concentration before the third daily dose of AZSTARYS. Steady-state
pharmacokinetics is a metric used to determine the time it takes
for drug levels to remain consistent in the body when administered
continuously.
“We are pleased that data highlighting AZSTARYS
were accepted for scientific presentation during the 2021 Psych
Congress,” said Travis Mickle, Ph.D., President and CEO of
KemPharm. “The results of the studies show the unique PK
profile of AZSTARYS that accounts for its rapid onset and extended
duration of effect. The research being presented at the 2021 Psych
Congress highlights key attributes of AZSTARYS that could be
potentially attractive to prescribers who are seeking innovative
treatments for controlling ADHD symptoms.”
The studies presented at the 2021 Psych Congress
were sponsored by KemPharm. The poster can be viewed via the
conference’s virtual platform and is also available under
“Publications & Posters” in the News & Publications section
of the Company’s website at http://www.kempharm.com.
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 $17.7 billion of revenue in 2020 with a
year-over-year prescription growth rate of approximately one
percent (~1%). Within this, the branded portion of the ADHD market
was approximately $7.6 billion in 2020, with extended-release
products representing more than 98% of the branded prescriptions.
In 2020, the methylphenidate segment of the ADHD market accounted
for approximately 19 million prescriptions and $4.5 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. Corium, Inc. is commercializing
AZSTARYS in the U.S.
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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