KemPharm Announces Research Involving Serdexmethylphenidate to be Featured in Two Poster Presentations at the APSARD 2022 Annual Conference
January 11 2022 - 7:30AM
KemPharm, Inc. (NasdaqGS: KMPH), a specialty pharmaceutical
company focused on the discovery and development of proprietary
prodrugs, announced today that research involving
serdexmethylphenidate (SDX), the company’s proprietary prodrug of
d-methylphenidate (d-MPH), will be featured in two poster
presentations during the American Professional Society of ADHD and
Related Disorders 2022 Annual Conference (APSARD 2022) being held
virtually January 13-16, 2022. Both posters will be presented by
Rene A. Braeckman, Ph.D., Vice President, Clinical Development for
KemPharm and will be accessible to registered meeting
attendees beginning January 13th.
SDX is the primary active pharmaceutical
ingredient in AZSTARYS®, a once-daily product for the treatment of
ADHD in patients aged six years and older, approved by the U.S.
Food and Drug Administration in March 2021, and being
commercialized by Corium, Inc. SDX is also the basis of several
other development-stage products being developed by KemPharm,
including KP879 (Stimulant Use Disorder) and KP1077 (Idiopathic
Hypersomnia). The U.S. Drug Enforcement Agency (DEA) has classified
SDX as a Schedule IV controlled substance, which is a lower
schedule than all other currently available methylphenidate-based
products.
The first poster, titled, “Mass Balance and
Metabolic Pathway Following Oral Administration of
[14C]-Serdexmethylphenidate, a Novel Prodrug of d-Methylphenidate,”
reported data from an open-label, single radiolabeled–dose,
nonrandomized study in eight healthy adult male subjects which
evaluated the absorption, metabolism, and excretion of SDX
following oral administration of radiolabeled 60 mg [14C]-SDX Cl
(molar equivalent to 30 mg d-MPH HCl). Results from the study
demonstrated that mass balance was achieved following
administration of SDX, which was converted to d-MPH without forming
novel major metabolites. The research also affirmed that conversion
of SDX to d-MPH likely occurs within the lower gastrointestinal
tract.
The second poster, titled, “Dose Proportionality
and Effects of Food on the Pharmacokinetics of Single-Entity
Serdexmethylphenidate (SDX),” reported on two studies involving
SDX, which examined the dose proportionality of SDX-derived d-MPH
after single doses of 20, 40, or 60 mg of SDX Cl and the effects of
food on the pharmacokinetics (PK) of SDX-derived d-MPH after
administration of 60-mg SDX Cl capsules. Results from the studies
concluded that key PK measures of SDX appeared to increase in a
dose-proportional manner with an increase in SDX dose and that food
did not impede the production or absorption of SDX-derived
d-MPH.
“The research being presented at APSARD 2022
highlights important PK properties of SDX that are believed to be
instrumental in the prodrug’s ability to enable a consistent and
smooth release of d-MPH,” said Travis Mickle, Ph.D., President and
CEO of KemPharm. “The results of these studies suggest that
SDX produces a dose-proportionate effect, is not impacted by the
presence or lack of food, and is fully absorbed, metabolized and
excreted following oral administration. For prescribers, these
attributes are recognized as key factors in converting patients to
AZSTARYS.”
The studies to be presented at APSARD 2022 were
sponsored by KemPharm. The posters will be available for viewing
via the conference’s “e-poster” platform on January 13th and
viewing will remain open until 30 days post-meeting. Following the
conference, the posters will be added to “Publications &
Posters” in the News & Publications section of the Company’s
website at http://www.kempharm.com.
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., a portfolio company of
Gurnet Point Capital, is leading all commercialization efforts for
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, and the recipient of the
2021 David J. Gury Company of the Year award presented by
BioFlorida. 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). In addition, the U.S. Food and Drug
Administration (FDA) has approved AZSTARYS®, a new once-daily
treatment for ADHD in patents age six years and older containing
KemPharm’s prodrug, serdexmethylphenidate (SDX), and APADAZ®, an
immediate-release combination product containing benzhydrocodone,
KemPharm’s 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,
include the ongoing commercialization of AZSTARYS®, and the
potential benefits of other KemPharm product candidates. 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, including market conditions and
the possibility that the share repurchase program may be suspended
or discontinued at any time. Risks concerning KemPharm’s business
are described in detail in KemPharm’s Quarterly Report on Form 10-Q
for the quarter ended September 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
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