EndeavorRxⓇ, World’s First and Only Prescription Video Game Treatment, Secures FDA Label Expansion for Pediatric ADHD Patients Aged 13-17
December 18 2023 - 8:00AM
Business Wire
Akili’s Clinically Proven Digital Medicine Now
Authorized for Children 8-17, Opening Option to More Patients as
Ongoing Stimulant Shortage Persists
Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company,
today announced that it has received authorization from the U.S.
Food and Drug Administration (FDA) to expand the label for
EndeavorRx® from 8 to 12 year-old patients with primarily
inattentive or combined-type ADHD who have a demonstrated attention
issue to include older children aged 13 - 17. This increased age
range is expected to more than double the number of pediatric
patients with ADHD who are now eligible for EndeavorRx – the only
FDA-authorized, game-based digital therapeutic – with a
prescription from a healthcare provider. (Akili also offers a
non-prescription product for adults with ADHD, using the same
technology, EndeavorOTC™.)
The clinical study on which the FDA’s label expansion
authorization for EndeavorRx is based involved 162 adolescents with
a verified diagnosis of inattentive or combined-type ADHD who all
received EndeavorRx for 4 weeks and subsequently demonstrated
significant improvements in TOVAⓇ-measured* attentional
control.
“This latest FDA authorization marks another significant
milestone for Akili and the Endeavor products, and more importantly
it provides access to adolescents, who have been disproportionately
impacted by the ongoing mental health crisis,” said Dr. Scott
Kollins PhD, Chief Medical Officer at Akili. “Our pivotal study for
adolescents demonstrates that EndeavorRx is a safe and effective
treatment option for millions of kids and teens struggling with
ADHD – particularly important given the ongoing stimulant
medication shortage.”
In the same study, adolescents using EndeavorRx also saw
significant improvement in clinician-rated ADHD symptoms, as
measured by the Attention Deficit Hyperactive Disorder Rating
Scale-5 (ADHD-RS) inattention subscale and total scale scores.
ADHD-RS is a clinician-administered questionnaire based on
information collected from the child's caregiver. Following
treatment, participants in the study showed significant improvement
on both the inattention subscale and total score of the ADHD-RS
(p<0.0001 for both). A prespecified responder analysis also
showed that 27.1% of all participants in the study demonstrated at
least a 30% reduction in total scores on the ADHD-RS, a finding
similar to the initial STARS-ADHD trial in 8-12 year old children
with ADHD (24%). Statistically significant improvements were also
observed for parent and child ratings of attention improvement, as
well as parent ratings of function across a number of domains,
including peer relationships, academic functioning, behavioral
functioning, homework functioning, and self-esteem. Overall, 4
(2.5%) participants experienced a treatment-emergent adverse device
event (3 decreased frustration tolerance, 1 headache; all mild or
moderate). There were no serious adverse device events.
About EndeavorOTC and EndeavorRx
Akili’s suite of cognitive treatment products for ADHD includes
EndeavorOTC and EndeavorRx. EndeavorOTC is a digital therapeutic
indicated to improve attention function, ADHD symptoms and quality
of life in adults 18 years of age and older with primarily
inattentive or combined-type ADHD. EndeavorOTC utilizes the same
proprietary technology underlying EndeavorRx, a prescription
digital therapeutic indicated to improve attention function in
children ages 8-17. EndeavorOTC is available under the U.S. Food
and Drug Administration’s current Enforcement Policy for Digital
Health Devices for Treating Psychiatric Disorders During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
EndeavorOTC has not been cleared or authorized by the U.S. Food and
Drug Administration for any indications. It is recommended that
patients speak to their health care provider before starting
EndeavorOTC treatment. No serious adverse events have been reported
in any of our clinical studies. To learn more, visit
EndeavorOTC.com.
EndeavorRx is indicated to improve attention function as
measured by computer-based testing in children ages 8 to 17 years
old with primarily inattentive or combined-type ADHD, who have a
demonstrated attention issue. Patients who engage with EndeavorRx
demonstrate improvements in a digitally assessed measure Test of
Variables of Attention (TOVA®) of sustained and selective attention
and may not display benefits in typical behavioral symptoms, such
as hyperactivity. EndeavorRx should be considered for use as part
of a therapeutic program that may include clinician-directed
therapy, medication and/or educational programs, which further
address symptoms of the disorder. EndeavorRx is available by
prescription only. It is not intended to be used as a stand-alone
therapeutic and is not a substitution for a child’s medication. The
most common side effect observed in children in EndeavorRx’s
clinical trials was a feeling of frustration, as the game can be
quite challenging at times. No serious adverse events were
associated with its use. EndeavorRx is recommended to be used for
approximately 25 minutes a day, 5 days a week, over initially at
least 4 consecutive weeks, or as recommended by your child’s health
care provider. To learn more about EndeavorRx, please visit
EndeavorRx.com.
About Akili
Akili is pioneering the development of cognitive treatments
through game-changing technologies. Akili’s approach of leveraging
technologies designed to directly target the brain establishes a
new category of medicine – medicine that is validated through
clinical trials like a drug or medical device, but experienced like
entertainment. Akili’s platform is powered by proprietary
therapeutic engines designed to target cognitive impairment at its
source in the brain, informed by decades of research and validated
through rigorous clinical programs. Driven by Akili’s belief that
effective medicine can also be fun and engaging, Akili’s products
are delivered through captivating action video game experiences.
For more information, please visit www.akiliinteractive.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended. These forward-looking statements generally are
identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “prepare,” “pursue,” “may,” “should,”
“will,” “would,” “will be,” “will continue,” “will likely result,”
and similar expressions. Forward-looking statements are
predictions, projections and other statements about future events
that are based on current expectations and assumptions and, as a
result, are subject to risks and uncertainties. These
forward-looking statements include, without limitation, statements
in this press release related to: our expectations regarding the
number of pediatric patients with ADHD who can now access
EndeavorRx and our ability to expand the use of EndeavorRx in those
patients in connection with the label expansion for EndeavorRx to
include adolescents ages 13 to 17 with ADHD; that the adoption and
efficacy of EndeavorRx in patients aged 13 to 17 with ADHD will be
similar to younger patients; and that the results of our clinical
studies are predictive of future clinical trials or results. Any
forward-looking statements in this press release are based on
management’s current expectations and beliefs and are subject to a
number of risks, uncertainties and important factors that may cause
actual events or results to differ materially from those expressed
or implied by any forward-looking statements contained in this
press release, including, without limitation, risks and
uncertainties related to: our ability to continue to commercialize
EndeavorRx in patients aged 13 to 17; our ability to obtain
regulatory clearance from FDA to convert our products to
over-the-counter-labeling; our ability to successfully create, and
navigate, a new category of medicine and to achieve broad adoption
of digital therapeutics among customers and healthcare providers;
our ability to continue to advance our clinical development
pipeline; our ability to defend our intellectual property and
satisfy various FDA and other regulatory requirements in and
outside of the United States; the risk of adverse macroeconomic or
political changes and a changing regulatory landscape in the highly
competitive industry in which we operate; the timing and results
expected from our and our partners’ clinical trials and our
reliance on third parties for certain aspects of our business; and
other risks identified in our current filings and any subsequent
filings made with the Securities and Exchange Commission. We
caution you not to place undue reliance on any forward-looking
statements, which speak only as of the date hereof and should not
be relied upon as representing our views as of any subsequent date.
We disclaim any obligation to publicly update or revise any such
statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements.
*Test of Variables of Attention
Akili and EndeavorOTC are trademarks of, and EndeavorRx is a
registered trademark of, Akili, Inc. TOVA is a registered trademark
of The TOVA Company. All rights reserved.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231218891755/en/
Media Akili, Inc.: Garth
Chouteau garth@akiliinteractive.com Launch
Squad: akili@launchsquad.com
Akili (NASDAQ:AKLI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Akili (NASDAQ:AKLI)
Historical Stock Chart
From Sep 2023 to Sep 2024