United States: The Food and Drug Administration (FDA) of the United States has provided approval for patients who suffer from clinical depression to take the new drug Rejoyn, a prescription digital drug.
More about the Rejoyn
Unlike any other digital health product, The Rejoyn app, developed by Otsuka Pharmaceutical and Click Therapeutics, is a smartphone app that is co-prescribed with antidepressants to 22 or older individuals who have a major depressive disorder.
It applies a multiweek program featuring cognitive-emotional training, as well as cognitive behavioral therapy lessons, as disclosed by a news release.
For Rejoyn to be cleared by the FDA, as a medical device with a classification of low- to medium-risk, it only needed to prove that it has the same level of safety and effectiveness as another marketed device. It just needed to be “substantially equivalent.”
Dr. John Kraus, executive vice president and chief medical officer at Otsuka, said, “Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care,” as CNN Health reported.
“While traditional approaches are often effective, many are left with only a partial response to treatment,” added Kraus.
More about mental illnesses – Report
From the mental disorders, the crisis of depression is the most prevalent one in the US. As the CDC points out, about 1 in 6, 18 percent of US adults by a recent Gallup- estate, expressed either this year that they are suffering from or under treatment for depression.
Another finding from the research is about 30 percent of the population who take antidepressant drugs are partial responders; that is, while the drugs are supposed to treat them, the patients still experience depressive symptoms.
Rejoyn is intended to be used in combination with antidepressant drugs for these individuals in comparison to the drug unaided improvement explained in the news release.
The app makes use of some well-established cognitive-emotional techniques known as the Emotional Faces Memory Task, in which people are asked to identify and compare different kinds of emotions.
Preliminary Neurological studies suggest that the given ones may stimulate the amygdala and dorsolateral prefrontal cortex regions – which are believed to be involved in depression – and have antidepressant properties.
Dr. Brian Iacoviello, scientific adviser at Click Therapeutics and a co-inventor of Emotional Faces Memory Task said, “Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression,” as CNN Health reported.