Unfortunately, developing medicines to treat mental illness has some of the lowest probabilities of success. This is due in large part to the inherent scientific challenges and complexities that come with developing medicines to treat these illnesses, including a limited understanding of the brain and the neurochemical pathways involved in these illnesses. Though the field of neuroscience has made advancements in recent years, there remains a significant gap in the larger understanding of how mental illnesses develop in the first place. This, combined with the extremely diverse nature of the diseases themselves — which often manifest differently in different people — have made it difficult to identify biomarkers that can aid in diagnosis, treatment and the development of medicines to treat these illnesses.  

Mental illness represents a broad spectrum of health conditions affecting mood, thinking and behavior. Fortunately, hope is on the horizon as biopharmaceutical research companies have made tremendous strides towards understanding mental illnesses and developing innovative medicines. Today, PhRMA released a new report covering 163 medicines in development that are targeting common mental illnesses, all of which are in clinical trials or awaiting review by the U.S. Food and Drug Administration (FDA). The promise of the pipeline is represented across a wide range of mental illnesses,

Otsuka America Pharmaceutical, Inc., and H. Lundbeck A/S announce the U.S. Food and Drug Administration acceptance of their New Drug Application for aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults. Aripiprazole 2-month, ready-to-use, long-acting injectable is provided in a single-chamber-type, prefilled syringe. It is intended for dosing every two months via intramuscular injection in the gluteal muscle.

Alkermes plc announced positive topline results from ENLIGHTEN-Early, a phase 3b study that evaluated the effect of LYBALVI® (olanzapine and samidorphan) compared to olanzapine on body weight in young adult patients (ages 16 to 39; mean age: 26 years) with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness. The study met its pre-specified primary endpoint, as patients treated with LYBALVI experienced statistically significantly less weight gain than patients treated with olanzapine at Week 12.