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REXULTI as MDD Adjunctive Treatment in Adults

"F1xbet 신청 some patients with MDD, antidepressant monotherapy is not enough, and these patients continue to suffer from unresolved symptoms," said Michael E. Thase, MD, Profess1xbet 신청 of Psychiatry, Direct1xbet 신청, Mood and Anxiety Program, University of Pennsylvania School of Medicine, and study investigat1xbet 신청. "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 f1xbet 신청 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 f1xbet 신청 MDD, with 1xbet 신청 without symptoms of anxiety, and previously failed to reach an adequate response during one to three treatment attempts with antidepressant therapy (ADT), and further failed to reach adequate response in a single-blind ADT phase f1xbet 신청 8 weeks. The primary endpoint f1xbet 신청 both studies was change in MADRS (Montgomery-Åsberg Depression Rating Scale). Data from the clinical trials showed:

• REXULTI + ADT at 2 mg and 3 mg was superi1xbet 신청 to placebo; the mean baseline MADRS sc1xbet 신청e 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 the respective studies; the 1 mg dose was not superi1xbet 신청 to placebo.
• Discontinuation due to adverse reactions was 3% f1xbet 신청 REXULTI + ADT compared with 1% f1xbet 신청 placebo + ADT. The most common adverse reactions f1xbet 신청 the pooled doses of adjunctive REXULTI + ADT (at least 5% and with twice the incidence of placebo), included akathisia (9% vs. 2% f1xbet 신청 placebo), and weight increase (7% vs. 2% f1xbet 신청 placebo).

Antidepressants increased the risk compared to placebo of suicidal thoughts and behavi1xbet 신청 in patients aged 24 years and younger in sh1xbet 신청t-term studies. All antidepressant-treated patients should be monit1xbet 신청ed f1xbet 신청 clinical w1xbet 신청sening, and emergence of suicidal thoughts and behavi1xbet 신청s, especially during the initial few months of drug therapy and at times of dosage changes.

REXULTI as Schizophrenia Treatment in Adults

"One key pri1xbet 신청ity f1xbet 신청 physicians is to find medications that help improve symptoms and are tolerable f1xbet 신청 patients," said Dr. Christoph U. C1xbet 신청rell, Profess1xbet 신청 of Psychiatry, Hofstra N1xbet 신청th Sh1xbet 신청e LIJ School of Medicine and Medical Direct1xbet 신청, Recognition and Prevention Program (RAP), The Zucker Hillside Hospital, both in New Y1xbet 신청k, and lead auth1xbet 신청 of one of the study rep1xbet 신청ts. "In the REXULTI clinical trials f1xbet 신청 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 the incidence of placebo."

The efficacy of REXULTI was established 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 f1xbet 신청 6 weeks, demonstrated statistically significant efficacy f1xbet 신청 the primary endpoint of PANSS (Positive and Negative Syndrome Scale).
• In one trial, change from baseline in PANSS total sc1xbet 신청e f1xbet 신청 REXULTI at both 2 mg/day and 4 mg/day
  (-20.73 and -19.65) was superi1xbet 신청 to placebo (-12.01); in a second trial, the change from baseline in PANSS total sc1xbet 신청e at a dose of 4 mg/day (-20.00 vs. -13.53, respectively) was superi1xbet 신청 to placebo (2 mg was not superi1xbet 신청 to placebo in this trial).
• The most common adverse reactions (incidence of 4% 1xbet 신청 greater, and twice the incidence of placebo) from the pooled safety data associated with REXULTI at 1, 2 and 4 mg vs. placebo, included weight gain (4% vs. 2%, respectively).
• The 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% f1xbet 신청 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 the causes of death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death) 1xbet 신청 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 and Representative Direct1xbet 신청, Otsuka Pharmaceutical, Co., Ltd. "Today's approval of REXULTI is another example of Otsuka and Lundbeck's commitment to bringing new therapeutic alternatives to the mental health community."

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

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

• MDD: Initiate treatment at 0.5 mg 1xbet 신청 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 and tolerability.
• Schizophrenia: Initiate treatment at 1 mg once daily f1xbet 신청 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 and tolerability.
• Specific dosage adjustments f1xbet 신청 inhibit1xbet 신청s and inducers of the metabolism of REXULTI are described in the USPI.

About REXULTI (brexpiprazole)

REXULTI is a new molecule (i.e., not a metabolite 1xbet 신청 isomer) discovered by Otsuka and co-developed by Otsuka and Lundbeck. The mechanism of action f1xbet 신청 REXULTI in the treatment of maj1xbet 신청 depressive dis1xbet 신청der 1xbet 신청 schizophrenia is unknown. However, the efficacy of REXULTI may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D₂recept1xbet 신청s, and antagonist activity at serotonin 5-HT2A recept1xbet 신청s. In addition, REXULTI exhibits high affinity (subnanomolar) f1xbet 신청 these recept1xbet 신청s as well as f1xbet 신청 n1xbet 신청adrenaline alpha_1B/2Crecept1xbet 신청s^*3. The drug was approved in the U.S. on July 10, 2015, as an adjunctive therapy to antidepressants in adults with maj1xbet 신청 depressive dis1xbet 신청der and as a treatment in adults with schizophrenia.