Otsuka Precision Health and Click Therapeutics Announce Launch of Rejoyn™, the First-And-Only Prescription Digital Therapeutic Cleared by the FDA for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Aug 13, 2024--

Otsuka Precision Health, Inc. (OPH) and Click Therapeutics, Inc., (Click) announce today the commercial launch of Rejoyn™. Rejoyn was cleared by the U.S. Food and Drug Administration (FDA) in March 2024 and is the first-and-only prescription digital therapeutic for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication.

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Patients can obtain a prescription for Rejoyn from their current provider or from another provider via a virtual consultation from Wheel Health, Inc., whose platform can be accessed from a link on the Rejoyn website. BlinkRx is the exclusive pharmacy provider for Rejoyn and will digitally dispense access codes for Rejoyn to prescribed patients. Rejoyn can then be downloaded from mobile application stores and used at a place and time of patients’ choosing. The option for a fully digital prescribing and dispensing pathway has the potential to remove friction and increase accessibility that can contribute to a better health experience for patients.

In an effort to facilitate broad access, the six-week Rejoyn treatment program is available for a limited time at a discounted price of $50 for patients. At launch, Rejoyn will be priced for payors at $200. Coverage from health insurers is expected to be forthcoming.

“We are proud to bring Rejoyn, the first-and-only FDA-cleared digital treatment for MDD symptoms, to market with transparent pricing that is affordable to most,” said Sanket Shah, president of Otsuka Precision Health. “This milestone has been over five years in the making and reflects the dedication, care, and evidence-based rigor with which we are developing digital treatments before putting them in the hands of patients.”

Rejoyn’s six-week brain exercises are designed to target and help alter those neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression. To this end, Rejoyn includes cognitive emotional brain training exercises called Emotional Faces Memory Task (EFMT) that tap into the brain’s natural ability to change, also known as neuroplasticity, plus short skills-based therapy lessons based on Cognitive Behavioral Therapy (CBT) that provide users with strategies and tools to help manage depression.

“Rejoyn offers healthcare providers a new and innovative way to treat patients who are looking for options beyond additional medication, or who haven’t responded to other therapies,” said Dr. Rakesh Jain, MD, MPH, psychiatrist and clinical professor, Department of Psychiatry at Texas Tech University School of Medicine, Permian Basin. “This time-limited treatment is a convenient option for patients who can be empowered to take treatment into their hands.”

The FDA clearance of Rejoyn was based on the Mirai study, a 13-week pivotal, remote, double-blinded, randomized, controlled trial of 386 participants, aged 22 to 64, diagnosed with MDD who were on antidepressant medication for the treatment of depression. Results showed that using Rejoyn reduced depression symptoms. Individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline. Symptom improvement was consistently observed across multiple patient and clinician-reported scales. One month after completing the six-week treatment program, participants in the Rejoyn group showed continued improvement. No side effects were assessed as related to Rejoyn during the trial. Full clinical data may be found as part of the Clinician Brief Summary.

“We all know someone with depression and the challenges in their treatment journey. There is no one-size-fits-all approach, which is why people continue to seek new options,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka Pharmaceutical Development & Commercialization, Inc., which conducted the Mirai study in collaboration with Click Therapeutics. “We’re excited that MDD patients and their healthcare providers now have a new treatment option that works alongside medication – with no related side effects or drug-interaction concerns.”

About

Rejoyn

Rejoyn (developed as CT-152), is the first FDA-cleared prescription digital therapeutic in the U.S. for the adjunctive treatment of major depressive disorder (MDD) symptoms.

Rejoyn (developed as CT-152), is the first FDA-cleared prescription digital therapeutic in the U.S. for the adjunctive treatment of major depressive disorder (MDD) symptoms.

Rejoyn requires a prescription from a healthcare provider and is available for download from app stores for iOS ® and Android™ operating systems. To learn more about Rejoyn, go to www.rejoyn.com. Healthcare providers can visit www.rejoynhcp.com.

For assistance with Rejoyn, call 1-833-973-5696 to access the nurse support line. Available Monday through Friday, 8:00 AM to 8:00 PM ET, excluding holidays.

INDICATION and SAFETY INFORMATION for Rejoyn

INDICATION:

Rejoyn is a prescription digital therapeutic for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct to the clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. It is intended to reduce MDD symptoms.

SAFETY INFORMATION:

Rejoyn is not intended to be used as a standalone therapy or a substitute for medication. Patients should continue their current treatment as directed.

Rejoyn is not intended to be used as a standalone therapy or a substitute for medication. Patients should continue their current treatment as directed.

Rejoyn does not monitor the patient’s symptoms or clinical status and cannot send or receive alerts or warnings to the prescriber.

Patients should be clearly instructed that if they believe their depression is worsening or if they have feelings or thoughts of harming themselves or others, to contact a healthcare professional, dial 911, or go to the nearest emergency room immediately.

About

Otsuka Precision Health

Combining the rigor of pharma with a data-first focus on patient experience, Otsuka Precision Health, Inc. focuses on bringing to market prescription digital therapeutics, other innovative technologies, and provides non-promotional patient support services. The company is committed to personalizing care, unlocking doors to access, and uniting a fragmented experience. OPH’s current focus areas include a variety of technological interventions that help unearth personal health needs and address them as a true collaborator within the broader healthcare ecosystem.

Combining the rigor of pharma with a data-first focus on patient experience, Otsuka Precision Health, Inc. focuses on bringing to market prescription digital therapeutics, other innovative technologies, and provides non-promotional patient support services. The company is committed to personalizing care, unlocking doors to access, and uniting a fragmented experience. OPH’s current focus areas include a variety of technological interventions that help unearth personal health needs and address them as a true collaborator within the broader healthcare ecosystem.

OPH is a subsidiary of Otsuka America, Inc. (Otsuka), which is a subsidiary of Otsuka Pharmaceutical Co., Ltd. headquartered in Tokyo, Japan.

For more information, please visit www.otsuka-oph.com.

About Click Therapeutics

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically validated, FDA-regulated prescription treatments to the smartphone in patients’ hands. The company’s treatments prioritize technical and scientific rigor as well as patient-centric design throughout the development process, which results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics is continuously expanding and refining its shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. Digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases.

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically validated, FDA-regulated prescription treatments to the smartphone in patients’ hands. The company’s treatments prioritize technical and scientific rigor as well as patient-centric design throughout the development process, which results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics is continuously expanding and refining its shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. Digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases.

For more information, visit www.clicktherapeutics.com and connect with the company on LinkedIn.

View source version on businesswire.com:https://www.businesswire.com/news/home/20240813220030/en/

CONTACT: Otsuka Precision Health

Frank Chavez

Head, Strategy & Corporate Development

Otsuka Precision Health

frank.chavez@otsuka-oph.comClick Therapeutics

Jonni Mills

Strategy & Communications Manager

Click Therapeutics

pr@clicktherapeutics.com

KEYWORD: UNITED STATES NORTH AMERICA NEW YORK NEW JERSEY

INDUSTRY KEYWORD: MENTAL HEALTH APPS/APPLICATIONS TECHNOLOGY NEUROLOGY FDA HEALTH TECHNOLOGY TELEMEDICINE/VIRTUAL MEDICINE GENERAL HEALTH PHARMACEUTICAL HEALTH

SOURCE: Otsuka Precision Health, Inc.

PUB: 08/13/2024 09:00 AM/DISC: 08/13/2024 09:01 AM

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