KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical
company focused on the discovery and development of proprietary
prodrugs, today announced that research involving AZSTARYS®
will be featured in a poster presentation during the 2021 Virtual
International Conference on ADHD, co-hosted by Children and Adults
with Attention-Deficit/Hyperactivity Disorder (CHADD) with the ADHD
Coaches Organization (ACO), and the Attention Deficit Disorder
Association (ADDA), taking place November 4-6, 2021.
The poster, titled,
“Serdexmethylphenidate/d-Methylphenidate Capsules for Children With
ADHD: Effects on SKAMP-C Evaluated Over 13 Hours in a Randomized,
Double-blind, Placebo-controlled Laboratory Classroom Study,”
detailed a multicenter, pivotal study that assessed the efficacy
and safety of AZSTARYS in 150 children aged 6 to 12 years with a
diagnosis of ADHD. Results indicated that the trial’s primary
endpoint was met, demonstrating significantly greater improvements
from baseline on the Swanson, Kotkin, Agler, M-Flynn, and Pelham
Scale (SKAMP) scale in subjects treated with AZSTARYS versus a
placebo (p<0.001). Results also showed the onset of treatment
effect began 30 minutes after dosing with AZSTARYS and continued
for 13 hours post dosing. Lastly, AZSTARYS was generally
well-tolerated with adverse events (AEs) typical of stimulant
therapy.
“We are very pleased that data from the pivotal
clinical trial of AZSTARYS were accepted for presentation during
the 2021 Virtual International Conference on ADHD,” said Travis
Mickle, Ph.D., President and CEO of KemPharm. “These efficacy
results formed the backbone of the New Drug Application that was
approved by the FDA and is now reflected in the product label for
AZSTARYS. No other FDA-approved ADHD drug offers such immediate and
long-lasting effect, which, when combined with its additional
attributes, makes AZSTARYS, in our view, the first truly
differentiated ADHD drug to be introduced in
decades.”
Approved by the U.S. Food and Drug
Administration (FDA) in March 2021, 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, is commercializing AZSTARYS in the U.S.
The data presented at the 2021 Virtual
International Conference on ADHD is from a study 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 It is estimated that 8.4% of
children and 2.5% of adults have ADHD.2, 3
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.
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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