Biotechs Develop Treatments Targeting Multiple Types of Mental Illness
It is estimated that approximately 25 percent of adults in the United States will deal with some form of mental illness within a given year. It’s also estimated that many of the people who experience these problems may never report it or seek help – despite a number of available therapies.
The month of May has been set aside of Mental health Awareness Month. Since 1949 the month has been used as a time to raise awareness of mental illness. Much like cancer or disease of the heart, there are multiple types of mental illnesses, including anxiety, depression, bipolar disorder, schizophrenia and obsessive-compulsive disorders. Many companies within the biotech industry have made it part of their mission to develop treatments to help people gain a measure of control over these types of disorders.
Of the varied types of mental illness, major headway has been made this year for the treatment of bipolar disorder patients.
In March the U.S. Food and Drug Administration (FDA) approved the expanded use of Sunovion Pharmaceuticals’ anti-psychotic drug Latuda (lurasidone HCI) for pediatric patients with major depressing episodes associated with bipolar disorder. Latuda had already been approved by the FDA as a monotherapy treatment for adults with depressive episodes associated with bipolar depression and for the treatment of adolescents and adults with schizophrenia. According to the late-stage trial data approval was based on, patients dosed with Latuda saw a statistically significant and clinically meaningful improvement in bipolar depression symptoms at six weeks compared to placebo. When the FDA approved the expanded use, the company hailed it as a victory for a group of patients that have few treatment options.
Bipolar disorder, which is also known as manic-depressive illness, causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks, according to the National Institute of Mental Health. It can impact people of all ages. Bipolar disorder is estimated to affect about 12.6 million people in the United States. Of those, about 50 to 66 percent of adults with bipolar disorder experience their first symptoms before the age of 18.
Another approval that is likely to treat those with major depressive disorder associated with bipolar I disorder is the team of Allergan and Gedeon Richter Ltd. Days before Sunovion snagged its new approval for Latuda, the team of Allergan and Gedeon Richter released topline results for RGH-MD-53, a Phase III study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder. Cariprazine, which is marketed as Vraylar, met its endpoints in the study, and the two companies are planning to seek regulatory approval as an add-on treatment. Last year Vraylar was approved by the U.S. Food and Drug Administration for the maintenance treatment of adults with schizophrenia. It was initially approved for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder in adults.
Bipolar I disorder is defined by manic episodes that last at least seven days and typically requires immediate hospital care.
It’s not easy for companies to gain regulatory approval for mental illness therapies. In April the FDA accepted Alkermes plc’s New Drug Application for ALKS-5461, a treatment for major depressive disorder. The approval was an about-face for the regulatory agency, which only weeks before rejected the company’s NDA. The FDA initially claimed Alkermes needed to conduct additional clinical trials, but following a Type A meeting the FDA changed course. The FDA will render a decision on the MDD treatment in January 2019.
Major depressive disorder (MDD) impacts about 17 million people each year. MDD is a condition in which patients exhibit depressive symptoms, which includes a depressed mood, a consistent loss of interest or pleasure in daily activities for at least a two-week period and also demonstrate impaired social, occupational, educational or other important functioning.
Another company that is planning to seek approval for a depression treatment is SAGE Therapeutics. In April Cambridge, Mass.-based Sage filed an NDA for brexanolone to treat postpartum depression (PPD), a disease that hits between 10 and 20 percent of new mothers annually in the United States.
More treatment options for various mental illnesses are in R&D pipelines as companies attempt to design therapies to help people live full and robust lives.