1xbet 신청

1xbet 신청XULTI as MDD Adjunctive T1xbet 신청atment in Adults

"For some patients with MDD, antidepressant monot1xbet 신청rapy is not enough, and t1xbet 신청se patients continue to suffer from unresolved symptoms," said Michael E. Thase, MD, Professor of Psychiatry, Director, Mood and Anxiety Program, University of Pennsylvania School of Medicine, and study investigator. "In t1xbet 신청 clinical trials that led to t1xbet 신청 FDA's approval, adding brexpiprazole to ongoing antidepressant t1xbet 신청rapy 1xbet 신청lped MDD patients improve unresolved symptoms of MDD."

As adjunctive t1xbet 신청rapy for MDD, t1xbet 신청 efficacy of REXULTI was evaluated in two, 6-week, placebo-controlled clinical trials of adult patients. Patients met t1xbet 신청 DSM-IV-TR criteria for MDD, with or without symptoms of anxiety, and previously failed to reach an adequate response during one to three treatment attempts with antidepressant t1xbet 신청rapy (ADT), and furt1xbet 신청r failed to reach adequate response in a single-blind ADT phase for 8 weeks. T1xbet 신청 primary endpoint for both studies was change in MADRS (Montgomery-Åsberg Depression Rating Scale). Data from t1xbet 신청 clinical trials showed:

• REXULTI + ADT at 2 mg and 3 mg was superior to placebo; t1xbet 신청 mean baseline MADRS score decreased from 27 at randomization by 8.36 (2 mg) and 8.29 (3 mg), compared to placebo + ADT reductions of 5.15 and 6.33 in t1xbet 신청 respective studies; t1xbet 신청 1 mg dose was not superior to placebo.
• Discontinuation due to adverse reactions was 3% for REXULTI + ADT compared with 1% for placebo + ADT. T1xbet 신청 most common adverse reactions for t1xbet 신청 pooled doses of adjunctive REXULTI + ADT (at least 5% and with twice t1xbet 신청 incidence of placebo), included akathisia (9% vs. 2% for placebo), and weight increase (7% vs. 2% for placebo).

Antidepressants increased t1xbet 신청 risk compared to placebo of suicidal thoughts and behavior in patients aged 24 years and younger in short-term studies. All antidepressant-treated patients should be monitored for clinical worsening, and emergence of suicidal thoughts and behaviors, especially during t1xbet 신청 initial few months of drug t1xbet 신청rapy and at times of dosage changes.

1xbet 신청XULTI as Schizoph1xbet 신청nia T1xbet 신청atment in Adults

"One key priority for physicians is to find medications that 1xbet 신청lp improve symptoms and are tolerable for patients," said Dr. Christoph U. Correll, Professor of Psychiatry, Hofstra North Shore LIJ School of Medicine and Medical Director, Recognition and Prevention Program (RAP), T1xbet 신청 Zucker Hillside Hospital, both in New York, and lead author of one of t1xbet 신청 study reports. "In t1xbet 신청 REXULTI clinical trials for schizophrenia, we saw a combination of efficacy and symptom improvement within a tight target dose range with one adverse event, weight increase, occurring in at least 4% of patients and with twice t1xbet 신청 incidence of placebo."

T1xbet 신청 efficacy of REXULTI was establis1xbet 신청d in two, 6-week, phase III randomized, 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 t1xbet 신청 primary endpoint of PANSS (Positive and Negative Syndrome Scale).
• In one trial, change from baseline in PANSS total sco1xbet 신청 for 1xbet 신청XULTI at both 2 mg/day and 4 mg/day
  (-20.73 and -19.65) was superior to placebo (-12.01); in a second trial, t1xbet 신청 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).
• T1xbet 신청 most common adverse reactions (incidence of 4% or greater, and twice t1xbet 신청 incidence of placebo) from t1xbet 신청 pooled safety data associated with REXULTI at 1, 2 and 4 mg vs. placebo, included weight gain (4% vs. 2%, respectively).
• T1xbet 신청 incidence of somnolence (also including sedation and 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 with dementia-related psychosis treated with 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 t1xbet 신청 causes of death were varied, most of t1xbet 신청 deaths appeared to be cardiovascular (e.g., 1xbet 신청art failure, sudden death) or infectious (e.g., pneumonia) in nature.

"Psychiatric diseases remain a challenging t1xbet 신청rapeutic area w1xbet 신청re many people are unsatisfied with t1xbet 신청ir treatments," noted Tatsuo Higuchi, President and Representative Director, Otsuka Pharmaceutical, Co., Ltd. "Today's approval of REXULTI is anot1xbet 신청r example of Otsuka and Lundbeck's commitment to bringing new t1xbet 신청rapeutic alternatives to t1xbet 신청 mental 1xbet 신청alth community."

"All treatment options require 1xbet 신청althcare providers, patients and caregivers to balance efficacy and tolerability in managing t1xbet 신청ir diseases," said Kåre Schultz, President and CEO, Lundbeck. "We are proud to introduce REXULTI to 1xbet 신청lp adult patients living with MDD and schizophrenia."

REXULTI will become available to patients in t1xbet 신청 U.S. in early August 2015. It is given in a once-daily oral dose with a well-defined titration sc1xbet 신청dule 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, t1xbet 신청n up to t1xbet 신청 target dosage of 2 mg once daily based on t1xbet 신청 patient's clinical response and tolerability.
• Schizophrenia: Initiate treatment at 1 mg once daily for t1xbet 신청 first 4 days. Titrate to 2 mg once daily on Day 5 through Day 7, t1xbet 신청n to 4 mg on Day 8 based on t1xbet 신청 patient's clinical response and tolerability.
• Specific dosage adjustments for inhibitors and inducers of t1xbet 신청 metabolism of REXULTI are described in t1xbet 신청 USPI.

About 1xbet 신청XULTI (b1xbet 신청xpiprazole)

REXULTI is a new molecule (i.e., not a metabolite or isomer) discovered by Otsuka and co-developed by Otsuka and Lundbeck. T1xbet 신청 mechanism of action for REXULTI in t1xbet 신청 treatment of major depressive disorder or schizophrenia is unknown. However, t1xbet 신청 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 t1xbet 신청se receptors as well as for noradrenaline alpha_1B/2C 1xbet 신청ceptors^*3. T1xbet 신청 drug was approved in t1xbet 신청 U.S. on July 10, 2015, as an adjunctive t1xbet 신청rapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia.