Princeton-based Otsuka Pharmaceutical and New York City-based Click Therapeutics, which specializes in developing software for medical treatments, have announced Food and Drug Administration clearance of Rejoyn, the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms.
Rejoyn is intended to reduce symptoms of major depressive disorder as an adjunct to clinician-managed outpatient care for adult MDD patients ages 22 and up who are on antidepressant medication.
Otsuka and Click signed a collaboration agreement in 2019 to develop and commercialize prescription digital therapeutics for treatment of MDD, with the intent to address unmet medical needs among this patient population and to improve outcomes. Rejoyn is the first FDA-cleared treatment resulting from this collaboration.
Rejoyn is a six-week treatment program designed to help enhance cognitive control of emotion through a combination of clinically validated cognitive emotional training exercises for the brain and brief therapeutic lessons. Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.
“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder (MDD) symptoms that complements the current standard of care,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “While traditional approaches are often effective, many are left with only a partial response to treatment. Otsuka has a long, unwavering commitment to addressing the unmet needs of people living with mental illnesses and the clearance of Rejoyn is an example of delivering on that promise.”
Rejoyn introduces clinically-validated cognitive emotional brain training exercises that were developed and studied by a team of psychologists, psychiatrists and neuroscientists. These 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.
The clearance of Rejoyn is based on data from the Mirai study, a 13-week pivotal, multicenter, 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. In the trial, patients were randomized to receive either Rejoyn or a sham control app. Individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline.
Rejoyn offers a novel approach to the treatment of depression symptoms as it is designed to target neural networks affected by depression and is hypothesized to leverage the brain’s inherent neuroplasticity to alter those connections leading to symptom reduction over time. Clinical research has long shown that chemical imbalances are not the only cause of depression, though most common treatments target these neurochemical abnormalities.
“The clearance of Rejoyn signals a fundamental change in how clinicians can treat symptoms of major depressive disorder,” said David Benshoof Klein, co-founder and CEO at Click Therapeutics. “It provides hope for those who are looking for new treatment options, especially one that is easily accessible through the device in the palm of your hand.”
Otsuka America Pharmaceutical, 508 Carnegie Center Drive, Princeton. 08540. 609-524-6788. www.otsuka-us.com.
