Amid growing mental health crisis, the product
release enables immediate access to non-drug treatment option as
Akili prepares FDA submission
Available nationwide without a prescription,
clinical data shows improvements in focus in 83% of adults with
ADHD
Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company,
today released EndeavorOTCTM, a new immersive mobile video game
treatment that is clinically proven to improve attention and focus,
specifically in adults with ADHD. EndeavorOTC is built on the same
technology as Akili’s EndeavorRxⓇ, the world’s first and only
FDA-authorized video game treatment now being prescribed for
children 8-12 years old with ADHD. EndeavorOTC is now available
without a prescription for adults 18 years and older
nationwide.
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the full release here:
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Adult playing EndeavorOTC to improve
attention and focus (Photo: Business Wire)
This announcement comes on the heels of recently announced
clinical trial data showing that EndeavorOTC (AKL-T01)
significantly improved focus, attention, and overall quality of
life in adults struggling with ADHD symptoms:
- 83% of participants reported clinical improvements in their
focus
- On average, participants’ ability to focus improved by 85%
- Over one-third of participants no longer exhibited an attention
deficit following treatment
- 73% of participants reported quality of life improvements,
including completing tasks on time, managing multiple tasks at
once, and keeping track of important items like wallets or
keys
Amid a persistent mental health crisis, an increasing number of
adults are seeking help for ADHD symptoms including inattention and
lack of focus while facing an ongoing nationwide shortage of ADHD
medication. As the gap between demand for care and availability of
effective treatments widens, Akili released EndeavorOTC under FDA’s
enforcement policy established shortly after the onset of the
COVID-19 pandemic to facilitate rapid access to certain low-risk,
mental health-related digital health devices.
“Compared with children, adults with ADHD are generally
overlooked and under-treated. Current treatments are not
sufficient, and adults need more effective options, including
non-pharmacological solutions. Untreated ADHD can affect an adult
in many adverse ways, from their personal to their professional
lives, causing undue stress and other significant mental health
challenges,” said Dr. Stephen Faraone, Distinguished Professor and
Vice Chair for Research, Department of Psychiatry, SUNY Upstate
Medical University and President of the World Federation for
ADHD.
"New, easily accessible treatments are needed to effectively
support adults with ADHD,” said Duane Gordon, President, Attention
Deficit Disorder Association (ADDA). “I’m delighted to see new
technology used to develop a unique approach to treatment, and a
video game treatment is a fun and engaging way to empower adults
with ADHD."
The release of EndeavorOTC provides immediate access to this
clinically-proven non-drug option for those seeking new safe and
effective solutions to their treatment needs. The first generation
of EndeavorOTC is available now in the Apple App Store® for adults
18 and older with ADHD. Akili will actively involve adults using
EndeavorOTC in the ongoing development of the product, gathering
feedback that will help shape future generations of the game. By
working closely with the community and embracing their perspective,
Akili will continue to enhance EndeavorOTC to make the experience
even more engaging, enjoyable and impactful.
“Without reliable access to ADHD medication or sufficient mental
healthcare professionals to meet demand, millions of Americans are
in urgent need of new validated and accessible treatment options.
Patients want better, and they want non-drug treatment options,”
said Eddie Martucci, chief executive officer of Akili. “The core
technology inside EndeavorOTC has helped thousands of children with
ADHD, and recently has shown it dramatically helped adults in our
clinical trial improve their focus, time management and
organizational skills, and their ability to keep track of important
items. We’re thrilled to make EndeavorOTC available to adults who
can benefit.”
Akili’s Endeavor suite of products, EndeavorOTC and EndeavorRx,
combine the best of medicine and mobile gaming and were developed
through the collaboration of world-renowned cognitive
neuroscientists and acclaimed entertainment and technology
designers. The digital treatments run on Akili’s patented Selective
Stimulus Management Engine (SSME™) core technology. SSME has been
validated in more than a dozen clinical trials across a variety of
diseases that impact cognition, including ADHD, depression,
multiple sclerosis, and autism spectrum disorder. By completing
tasks while simultaneously filtering out distractions, the
treatments target areas of the brain responsible for cognitive
functions including focus, which helps improve attention and
day-to-day functioning. Algorithms adapt to each user in real time,
delivering a personalized experience and challenging the user at an
optimized level to improve the targeted cognitive function.
EndeavorOTC is now available for download on the Apple App
Store®, and those who sign up for the mailing list will be notified
when it becomes available on Android. For more information, visit
EndeavorOTC.com.
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 8-12. 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
its 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 12 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,” “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: the ability of
EndeavorOTC to improve attention function, ADHD symptoms and
quality of life in adults with ADHD and the growing need for ADHD
treatment and non-pharmacological options. 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:
the risk that prior results, such as signals of efficacy or safety
observed from clinical trials will not continue or be repeated in
EndeavorOTC or our ongoing or planned clinical trials, or will be
insufficient to support regulatory submissions or support or
maintain marketing approval in the United States or other
jurisdictions, or that long-term adverse safety findings may be
discovered; the risk that our products will not be further
developed or commercialized successfully; the timing and results
expected from our and our partners’ clinical trials and our
reliance on third parties for certain aspects of our business; our
ability to accurately estimate expenses, capital requirements, and
needs for additional financing; and other risks identified in our
current filings and any subsequent filings made with the Securities
and Exchange Commission (SEC). 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 the
company’s 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230607005233/en/
Julie DiCarlo SVP, Communications PR@AkiliInteractive.com
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