About aripiprazole once-monthly
Aripiprazole once-monthly is a sterile, lyophilized cake that when reconstituted with sterile water for injection, forms an injectable suspension. This formulation has been evaluated as a once-monthly injection for the maintenance treatment of schizophrenia.

Otsuka's Aripiprazole Intramuscular Depot Study in Schizophrenia-US is a phase III clinical study of the once-monthly formulation of aripiprazole that was designed to evaluate the efficacy, safety and tolerability of the intramuscular formulation as a maintenance treatment in patients with schizophrenia. The US registration study (31-07-246) was a multicentre, randomised, double-blind, placebo-controlled study, originally scheduled for a 52 week duration, which incorporated an interim analysis after achievement of 50% of the 125 events needed to complete the study. This interim analysis was conducted in June 2010, and the independent data monitoring committee determined that the interim analysis met the established termination criteria and recommended that the study be stopped.

The compound is co-developed with Otsuka Pharmaceuticals Co., Ltd.

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About schizophrenia
Schizophrenia is a severe, disabling and, most often, chronic brain disorder with a considerable impact on the patients' quality of life. Furthermore, schizophrenia affects the patients' family, service systems and society as a whole.

As a chronic illness its costs to society are persistent. Schizophrenia is prevalent among a relatively small group of the population, but not least owing to its serious nature, the disease places a disproportionately large economic burden upon society.

About Lu AF35700
Lu AF35700 has a novel pharmacological profile with predominant D1 vs. D2 dopamine receptor occupancy, and a high occupancy of 5-HT2A and 5-HT6 serotonin receptors.

The relatively low dopamine D2 receptor occupancy of Lu AF35700 is expected to result in reduced burden of adverse events, such as EPS, prolactin elevation, dysphoria/anhedonia, and depressed mood. In completed safety trials, Lu AF35700 was generally well tolerated with a beneficial safety profile.

In November 2015, FDA granted Fast Track designation for Lu AF35700 - a first important step to ensure a potential expedited approval of the compound.

For more information and study locations, please visit www.clinicaltrials.gov.

About treatment resistant schizophrenia (TRS)
Schizophrenia is a chronic, severe mental health disorder that often become disabling. Around 30% of patients with schizophrenia fail to respond to pharmacological treatment and are considered treatment resistant[ii]. These patients account for a significant part of the health care costs associated with schizophrenia including hospitalization and other health resource utilization.

Clozapine is the only medication with proven efficacy in treatment resistant schizophrenia, but is often not well tolerated, and requires regular monitoring as it is associated with a number of serious safety issues, which limits its use.

About Rexulti
Brexpiprazole (Rexulti™) is a new molecule (i.e., not a metabolite or isomer) discovered by Otsuka and co-developed by Otsuka and Lundbeck. The mechanism of action for Rexulti in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of Rexulti may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. In addition, Rexulti exhibits high affinity (subnanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors. The drug was approved in the US on 10 July, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia.

For more information and study locations, please visit www.clinicaltrials.gov.

About schizophrenia
Schizophrenia is a common form of severe mental illness that carries a notable 'stigma' and is often misunderstood. People with schizophrenia experience disturbed thoughts, emotions and behaviour, and they find it difficult to judge reality. This can have a major impact on the life of the individual and his/her family. Schizophrenia is caused by an imbalance in the chemicals that send signals to the brain, leading to the perception (seeing/hearing/thinking) of things that are not real. The factors that create this imbalance are not fully understood. Schizophrenia is characterised by episodes of psychosis (losing touch with reality) in between periods of blunted emotions and withdrawal.

About Rexulti
Brexpiprazole (Rexulti™) is a new molecule (i.e., not a metabolite or isomer) discovered by Otsuka and co-developed by Otsuka and Lundbeck. The mechanism of action for Rexulti in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of Rexulti may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. In addition, Rexulti exhibits high affinity (subnanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors. The drug was approved in the US on 10 July, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia.

For more information and study locations, please visit www.clinicaltrials.gov.

About depression
Depression is a common medical condition that is associated with a wide range of emotional and physical symptoms. These symptoms can have a great impact on daily life. People suffering from depression may no longer have control over their moods or feelings, and they tend to feel low almost all the time. Consequently, they may have trouble holding on to their job, keeping up with their studies, and/or maintaining their family life and social contacts. Depression can strike anyone, but various social and biological factors can increase a person's risk of developing the disorder. In addition, stressful experiences such as illness, unemployment or bereavement may trigger the condition in some people. Depression affects people in different ways, but is more than just 'feeling down' for a short while. Due to chemical changes in the brain, people with depression may experience long-lasting feelings of sadness and anxiety, have unexplained aches and pains, and suffer from poor quality of sleep and/or lack of interest and energy. These symptoms may persist for weeks, months or years. At its most serious, depression can lead to suicidal thoughts and self-harm.

About Rexulti
Brexpiprazole (Rexulti™) is a new molecule (i.e., not a metabolite or isomer) discovered by Otsuka and co-developed by Otsuka and Lundbeck. The mechanism of action for Rexulti in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of Rexulti may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. In addition, Rexulti exhibits high affinity (subnanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors. The drug was approved in the US on 10 July, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia.

The studies compare efficacy of doses of Rexulti with placebo in subjects with agitation associated with dementia of the Alzheimer's type.

For more information and study locations, please visit www.clinicaltrials.gov.

About Alzheimer's disease
Alzheimer's disease is a devastating disease, with an insidious onset and relentless progress. It produces distressing changes in memory, thought, perception, and often behaviour. These changes increasingly impact the patient's daily life, reducing functional independence, until ultimately, the patients are entirely dependent on others. Alzheimer's disease is a progressive disease, where the neurons in the brain gradually degenerate. One of the consequences of this degeneration of the brain is an increased level of cellular waste between the neurons, known as plaques and tangles. As the disease progresses, the physical volume of the brain decreases as more and more neurons die. Alzheimer's disease is the most common cause of dementia. It accounts for up to 80% of all dementia cases. Studies show that as many as 5% of all people above the age of 65 will develop Alzheimer's disease.

About Abilify Maintena®
Abilify Maintena (aripiprazole once-monthly) is the first and only once-monthly injection of a dopamine D2 partial agonist. It is available in the US for the treatment of schizophrenia and in a number of European countries for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. In Canada it is available for the maintenance treatment of schizophrenia in stabilized adult patients and in Australia for maintenance of clinical improvement in the treatment of schizophrenia.

Abilify Maintena, an atypical antipsychotic, is an intramuscular depot formulation of aripiprazole. It is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. After an initial injection of Abilify Maintena along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of Abilify Maintena provide uninterrupted medication coverage for 30 days at a time. It provides a treatment option to address two of the most important considerations in the management of schizophrenia — improving symptoms in patients with an acute relapse of their disease and reducing the risk of relapse or the re-emergence of worsening of symptoms. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range for an extended period of time.

In August 2012, Lundbeck and Otsuka Pharmaceuticals initiated a randomized, double-blind, placebo-controlled trial to assess the time to recurrence of any mood episode in individuals with bipolar I disorder who have maintained stability on Abilify Maintena for at least 8 weeks. The study is expected to recruit approximately 700 patients in the US, Canada, EU and Asia and is expected to be finalized by mid-2016.

For more information and study locations, please visit www.clinicaltrials.gov.

About bipolar I disorder
Bipolar I disorder is a chronic (long-term) and debilitating psychiatric illness characterised by repeated episodes of mania and depression, or a mixture of both. Bipolar I disorder is a sub-type of bipolar disorder – a severe mental illness, previously called manic-depressive psychosis. It is characterised by periods of altered mood, which may be manic, depressive or mixed (i.e., alternating rapidly between mania and depression). These intense moods often lead to problems with daily functioning, ruined personal relationships and suicide attempts. The first manic episode, necessary for making a diagnosis of bipolar I disorder, is frequently preceded by one or more depressive episodes.