1xbet 신청

1xbet 신청 as MDD Adjunctive Treatment in Adults

"For some patients with MDD, antidepressant monotherapy is not enough, 1xbet 신청 these patients continue to suffer from unresolved symptoms," said Michael E. Thase, MD, Professor of Psychiatry, Director, Mood 1xbet 신청 Anxiety Program, University of Pennsylvania School of Medicine, 1xbet 신청 study investigator. "In the clinical trials that led to the FDA's approval, adding brexpiprazole to ongoing antidepressant therapy helped MDD patients improve unresolved symptoms of MDD."

As adjunctive therapy for MDD, the efficacy of REXULTI was evaluated in two, 6-week, placebo-controlled clinical trials of adult patients. Patients met the DSM-IV-TR criteria for MDD, with or without symptoms of anxiety, 1xbet 신청 previously failed to reach an adequate response during one to three treatment attempts with antidepressant therapy (ADT), 1xbet 신청 further failed to reach adequate response in a single-blind ADT phase for 8 weeks. The primary endpoint for both studies was change in MADRS (Montgomery-Åsberg Depression Rating Scale). Data from the clinical trials showed:

• REXULTI + ADT at 2 mg 1xbet 신청 3 mg was superior to placebo; the mean baseline MADRS score decreased from 27 at r1xbet 신청omization by 8.36 (2 mg) 1xbet 신청 8.29 (3 mg), compared to placebo + ADT reductions of 5.15 1xbet 신청 6.33 in the respective studies; the 1 mg dose was not superior to placebo.
• Discontinuation due to adverse reactions was 3% for REXULTI + ADT compared with 1% for placebo + ADT. The most common adverse reactions for the pooled doses of adjunctive REXULTI + ADT (at least 5% 1xbet 신청 with twice the incidence of placebo), included akathisia (9% vs. 2% for placebo), 1xbet 신청 weight increase (7% vs. 2% for placebo).

Antidepressants increased the risk compared to placebo of suicidal thoughts 1xbet 신청 behavior in patients aged 24 years 1xbet 신청 younger in short-term studies. All antidepressant-treated patients should be monitored for clinical worsening, 1xbet 신청 emergence of suicidal thoughts 1xbet 신청 behaviors, especially during the initial few months of drug therapy 1xbet 신청 at times of dosage changes.

1xbet 신청 as Schizophrenia Treatment in Adults

"One key priority for physicians is to find medications that help improve symptoms 1xbet 신청 are tolerable for patients," said Dr. Christoph U. Correll, Professor of Psychiatry, Hofstra North Shore LIJ School of Medicine 1xbet 신청 Medical Director, Recognition 1xbet 신청 Prevention Program (RAP), The Zucker Hillside Hospital, both in New York, 1xbet 신청 lead author of one of the study reports. "In the REXULTI clinical trials for schizophrenia, we saw a combination of efficacy 1xbet 신청 symptom improvement within a tight target dose range with one adverse event, weight increase, occurring in at least 4% of patients 1xbet 신청 with twice the incidence of placebo."

The efficacy of REXULTI was established in two, 6-week, phase III r1xbet 신청omized, placebo-controlled clinical trials with fixed doses of REXULTI vs. placebo. Clinical trial data showed:

• REXULTI, at an adequate dose for 6 weeks, demonstrated statistically significant efficacy for the primary endpoint of PANSS (Positive 1xbet 신청 Negative Syndrome Scale).
• In one trial, change from baseline in PANSS total score for REXULTI at both 2 mg/day 1xbet 신청 4 mg/day
  (-20.73 1xbet 신청 -19.65) was superior to placebo (-12.01); in a second trial, the change from baseline in PANSS total score at a dose of 4 mg/day (-20.00 vs. -13.53, respectively) was superior to placebo (2 mg was not superior to placebo in this trial).
• The most common adverse reactions (incidence of 4% or greater, 1xbet 신청 twice the incidence of placebo) from the pooled safety data associated with REXULTI at 1, 2 1xbet 신청 4 mg vs. placebo, included weight gain (4% vs. 2%, respectively).
• The incidence of somnolence (also including sedation 1xbet 신청 hypersomnia) in all patients with schizophrenia who received REXULTI (n=1,256) was 4.9% compared to 3.2% for patients receiving placebo (n=463).

Elderly patients 1xbet 신청 dementia-related psychosis treated 1xbet 신청 antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although the causes of death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

"Psychiatric diseases remain a challenging therapeutic area where many people are unsatisfied with their treatments," noted Tatsuo Higuchi, President 1xbet 신청 Representative Director, Otsuka Pharmaceutical, Co., Ltd. "Today's approval of REXULTI is another example of Otsuka 1xbet 신청 Lundbeck's commitment to bringing new therapeutic alternatives to the mental health community."

"All treatment options require healthcare providers, patients 1xbet 신청 caregivers to balance efficacy 1xbet 신청 tolerability in managing their diseases," said Kåre Schultz, President 1xbet 신청 CEO, Lundbeck. "We are proud to introduce REXULTI to help adult patients living with MDD 1xbet 신청 schizophrenia."

1xbet 신청 will become available to patients in the U.S. in early August 2015. It is given in a once-daily oral dose with a well-defined titration schedule that can be taken with or without food.

• MDD: Initiate treatment at 0.5 mg or 1 mg once daily. Titrate at weekly intervals to 1 mg once daily, then up to the target dosage of 2 mg once daily based on the patient's clinical response 1xbet 신청 tolerability.
• Schizophrenia: Initiate treatment at 1 mg once daily for the first 4 days. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on the patient's clinical response 1xbet 신청 tolerability.
• Specific dosage adjustments for inhibitors 1xbet 신청 inducers of the metabolism of REXULTI are described in the USPI.

About 1xbet 신청 (brexpiprazole)

REXULTI is a new molecule (i.e., not a metabolite or isomer) discovered by Otsuka 1xbet 신청 co-developed by Otsuka 1xbet 신청 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 1xbet 신청 dopamine D₂receptors, 1xbet 신청 antagonist activity at serotonin 5-HT2A receptors. In addition, REXULTI exhibits high affinity (subnanomolar) for these receptors as well as for noradrenaline alpha_1B/2Creceptors^*3. The drug was approved in the U.S. on July 10, 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder 1xbet 신청 as a treatment in adults with schizophrenia.