About Aripiprazole depot formulation
Aripiprazole depot formulation 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 depot 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.

For more information, please click here.

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 nalmefene
Nalmefene is an opioid system modulator with a distinct mu, delta, and kappa profile¹. Evidence suggests it acts at the cortical mesolimbic circuit to help regulate alcohol consumption. Nalmefene has been studied for use in substance use disorders since the 1990s.

Use of nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, the treatment with nalmefene can be used on an as-needed basis allowing individuals to be in control of their treatment and limit the intake of alcohol rather than requiring full abstinence. Reduction of alcohol consumption to less harmful levels is supported by specialists^2,3 as a valuable treatment option to keep the individuals in treatment and to increase the willingness among patients to initiate treatment. Nalmefene is the first and only drug aimed at being indicated for the reduction of alcohol consumption in alcohol dependent patients.

Three studies in the overall phase III clinical programme were conducted in Europe and enrolled about 2,000 individuals with alcohol dependence.  It is worth mentioning that approximately two thirds of the patients in the studies had never been treated for alcohol dependence before, indicating that reduction of alcohol is indeed an attractive treatment goal for patients who had previously been reluctant to seek treatment, thus lowering the treatment barrier

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

About alcohol dependence

• Alcohol dependence is a CNS disorder, with a high risk of a chronic, relapsing and progressive course⁴
• In EU, 5.0% of adult men and 1.4% of adult women are estimated to be alcohol dependent in any one year⁵.
• More than 80% of alcohol dependent people worldwide remain undiagnosed. Of those diagnosed, only a small fraction, around 10%, receives treatment⁶.
• Among people with alcohol dependence relapse rates are high. Long-term relapse rates among individuals who are treated to achieve short-term remission have varied between 20 and 80%⁷.

¹ Gal TJ et al. Prolonged blockade of opioid effect with oral nalmefene. Clin Pharmacol Ther. 1986 Nov;40(5):537-42.

² Jürgen Rehm et al. Epidemiology and alcohol policy in Europe.  Addiction 2011;106(Suppl 1):11–19

³ Diane E. Logan and G. Alan Marlatt. Harm Reduction Therapy: A Practice-Friendly Review of Research. J Clin Psychol. 2010 Feb;66(2):201-14.

⁴ Leshner AI. Addiction is a brain disease, and it matters. Science. 1997 Oct 3;278(5335):45-7.

⁵ Rehm J et al. Alcohol use disorders in EU countries and Norway: an overview of the epidemiology. Eur Neuropsychopharmacol. 2005 Aug;15(4):377-88

⁶ VisionGain, 2008

⁷ Moss & Moss, Addiction 2006b;101(2):212-222

About Lu AA21004
Lu AA21004 is a multimodal antidepressant that is thought to work through a combination of two pharmacological modes of action: reuptake inhibition and receptor activity.  In vitro studies indicate that Lu AA21004 is a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter. In vivo nonclinical studies have demonstrated that Lu AA21004 enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain.

Lu AA21004 has demonstrated in preclinical models that it provides enhanced efficacy and available clinical data show encouraging results for the potential efficacy and the tolerability profile of Lu AA21004:

• A European based 560-patient placebo-controlled MDD study shows statistical significance on the primary efficacy endpoint across all tested doses.
• Additionally a 639-patient relapse prevention study shows statistical significance in maintenance of efficacy in long-term treatment of MDD.
• Supportive study shows separation from placebo with 5 and 10 mg doses.
• Finally, the proof of concept study (clinical phase II) shows statistical significance on all tested doses

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

About depression
Depression is a disease that affects a large proportion of the population, and it is also one of the most disabling diseases.

The symptoms of depression can be chronic or recurrent, and impact patients both mentally and physically, yet it is still under-recognised and undertreated. Symptoms can include feelings of sadness, anxiety, loss of interest in activities, decreased energy, impaired sleep, impaired concentration, hopelessness, guilt, persistent physical symptoms such as pain and digestive disorders, and in more sever cases, suicidal thoughts and suicidal attempts.

About I.V. Carbamazepine
IV carbamazepine is a novel formulation of the widely used oral antiepileptic drug (AED) carbamazepine. As the potential first and only injectable form of the drug, IV carbamazepine is an important alternative for patients with epilepsy who may be hospitalized or otherwise temporarily unable to take oral carbamazepine. This clinical trial is designed to evaluate the bioequivalence of the intravenous doses with oral doses as well as assess the safety, tolerability and pharmacokinetics of IV carbamazepine relative to orally administered carbamazepine.

IV Carbamazepine as an oral preparation has a well-established therapeutic profile with nearly 40 years of clinical use in the United States and around the world. It is used in the management of complex partial seizures, as an adjunct in some patients with secondary or partial epilepsy (epilepsy originating in one area of the brain) with complex symptomatology or secondarily generalized seizures (partial seizures followed by epileptic activity in the entire brain) when administered in combination with other antiepileptic drugs (AEDs). It has also been found useful as an alternative medication in patients with generalized tonic-clonic seizures (the most common type of generalized seizures) who are experiencing marked side effects or fail to respond to other anticonvulsants.

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

About epilepsy
According to the Epilepsy Foundation, there are approximately 2.7 million adults with epilepsy in the United States, making it the third most common neurological disorder in adults after Alzheimer's disease and stroke. Epilepsy is a neurological condition affecting the nervous system that produces seizures-which are sudden surges of electrical activity in the brain that usually affect how a person feels or acts. Some seizures can hardly be noticed, while others are totally disabling. The seizures in epilepsy may be related to a brain injury or genetic tendency, but most of the time the cause is unknown.

About OPC-34712
OPC-34712 is a novel investigational psychotherapeutic compound developed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia). The compound has broad activity across multiple monoamine systems and exhibits reduced partial agonist activity at D2 dopamine receptors and enhanced affinity for specific serotonin receptors. OPC-34712 has entered into clinical phase III trial for schizophrenia and adjunctive treatment of MDD.

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

For more information, please click here.

About desmoteplase
Desmoteplase is a novel, highly fibrin-specific thrombolytic agent in phase III of clinical development. In 2009, two large trials (DIAS-3 and DIAS-4) were started (www.clinicaltrials.gov: NCT00790920 & NCT00856661), each planned to enrol 400 patients worldwide who has had an acute ischaemic stroke. The results of these studies will determine whether desmoteplase will gain marketing authorization as a safe and effective treatment for patients with acute ischaemic stroke. Filing with health authorities is estimated in the first half of 2014.

Desmoteplase is a chemical found in the saliva of vampire bats that has the effect of catalysing the conversion of plasminogen to plasmin, which is the enzyme responsible for breaking down fibrin blood clots. The structure of desmoteplase is similar to rtPA (alteplase), but it does not contain the plasmin-sensitive cleavage site and the lysine-binding Kringle 2 domain. As a result, desmoteplase, in comparison to rtPA, has high fibrin selectivity (100,000- v. 550-fold increase in catalytic activity), an absence of neurotoxicity, and no apparent negative effect on the blood-brain barrier. Desmoteplase also has a half-life of about 4 hours [3]; rtPA (alteplase) has a terminal plasma half-life of about 5 minutes.

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

About stroke
Stroke is the third leading cause of death in the industrialised world behind heart disease and cancer. The treatment of acute stroke and its serious long-term disabilities currently present an extensive unmet need. The only drug currently approved for the treatment of acute ischaemic stroke must be administered within 3 hours after the onset of stroke symptoms, which limits the potential patient population that can safely benefit from the rapid dissolution of the blood clot and the restoration of blood supply to the affected area of the brain.

About zicronapine
Zicronapine (previously known as Lu 31-130) is in clinical development for the treatment of psychosis on the basis of pharmacological data indicating antipsychotic activity combined with a reduced side-effect liability in vivo. Zicronapine is an atypical antipsychotic potentially capable of treating different psychotic symptoms.

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

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 AA24530
Lu AA24530 was selected as a development candidate based on its convincing effect in preclinical animal models suggesting fast onset of action and increased efficacy in the treatment of depression.

In pre-clinical studies, Lu AA24530 has demonstrated activities as a monoamine enhancer with reuptake inhibition at monoamine transporters, and antagonist activity at 5-HT3  and 5-HT2c 

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

About depression
Depression is a disease that affects a large proportion of the population, and it is also one of the most disabling diseases.

The symptoms of depression can be chronic or recurrent, and impact patients both mentally and physically, yet it is still under-recognised and undertreated. Symptoms can include feelings of sadness, anxiety, loss of interest in activities, decreased energy, impaired sleep, impaired concentration, hopelessness, guilt, persistent physical symptoms such as pain and digestive disorders, and in more sever cases, suicidal thoughts and suicidal attempts.

About Lu AE58054
Lu AE58054 is a potent and selective so-called 5-HT6 receptor antagonist. The 5-HT6 receptor is primarily found in areas of the brain involved in cognition. Early trials have demonstrated that 5-HT6 could offer potential in the treatment of Alzheimer's disease, but also other diseases that may lead to cognitive disturbances.

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 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.