Discover REXULTI® (brexpiprazole):

[Virtual Presenter] Today I am here to talk about rexulti® (brexpiprazole) a potentially effective therapy for major depressive disorder. Studies have shown that when used as an adjunctive therapy with an antidepressant rexulti® (brexpiprazole) can reduce symptoms in adults beyond what is achievable with an antidepressant alone. Therefore I am enthusiastic to introduce rexulti® (brexpiprazole) as an adjunctive therapy for major depressive disorder..

[Audio] rexulti® is a medication developed as an adjunct therapy for major depressive disorder available in 2 milligrams tablets and other dosage strengths to be taken once daily with or without food. However it is advised to keep in mind the warnings associated with the use of rexulti. Patients aged 24 and under have an increased risk of suicidal thoughts and behavior compared to placebo in short term studies. Additionally rexulti increases the risk of death in elderly patients with dementia-related psychosis thus requiring close observation and alerting of a healthcare provider..

[Audio] From the chart on this slide only 49% of 3671 adult patients with non-psychotic major depressive disorder from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial achieved adequate response to their step 1 treatment of 12 weeks of monotherapy with an S-S-R-I-. As the number of treatment steps increased the response rates also increased up to 16% in the fourth step which included switching to M-A-O-I or an antidepressant combination therapy. These results imply that further treatments may be required for those not obtaining a response with the initial course of therapy..

[Audio] When evaluating available treatment options for major depressive disorder it may be beneficial to consider rexulti® as a potentially effective adjunctive therapy. Determining whether prescribed pharmacotherapies are meeting treatment goals and the needs of patients is an important factor to consider when looking for a treatment..

[Audio] Results from the STAR*D trial indicated that only 26.1% to 28.2% of patients who had switched to a second-line antidepressant after not responding to their initial selective serotonin reuptake inhibitor (S-S-R-I-) therapy were successful in obtaining the desired response. Studies suggest that adjunctive therapy such as rexulti® (brexpiprazole) may be beneficial in order to improve patient outcomes..

[Audio] Patients with unresolved major depressive disorder (M-D-D--) symptoms may benefit from an additional therapy such as an atypical antipsychotic. Studies have shown that this is more efficacious than the placebo however dose reduction and management of side effects is essential to maximize exposure to treatment and obtain a desirable response. Furthermore the use of adjunctive atypical antipsychotics for M-D-D is correlated with weight gain metabolic complications and other potential adverse effects. Thus the goals of adjunctive therapy for M-D-D are to reduce side effects while maximizing efficacy..

[Audio] As we know when a patient has been diagnosed with Major Depressive Disorder they may require additional therapies alongside antidepressants to improve their symptoms. This is where rexulti® an adjunctive therapy comes in. This compound has been approved by the relevant authorities as a potential treatment option that could help patients make even greater improvements in their mental health. rexulti® is made from brexpiprazole and it has been shown to help reduce the severity of the symptoms of major depressive disorder. We invite you to learn more about it and to discuss with your healthcare provider if this might be a potential treatment option for you..

[Audio] Brexpiprazole exhibits both serotonin 5-HT1 ampere partial agonist activity and serotonin 5-HT2 ampere receptor antagonist activity making it a possible compound for adjunctive therapy in major depressive disorder.2.

[Audio] The rexulti® clinical studies trial design was discussed. Adult patients diagnosed with major depressive disorder including those with anxiety participated based on having an inadequate response to a previous antidepressant as evidenced by a HAM-D score greater than 18 and less than 50% reduction in Antidepressant Treatment History Questionnaire. Single-blind escitalopram fluoxetine paroxetine CR sertraline duloxetine or venlafaxine XR was administered in the prospective phase after which patients who did not respond to antidepressant monotherapy were randomized to receive rexulti®. These patients had to have a 17-item Hamilton Rating Scale for Depression score of 14 or higher and less than a 50% reduction in HAM-D17 and madrs total score from baseline..

[Audio] At randomization the population enrolled in Studies 1 and 2 had comparable characteristics in the rexulti® and placebo arms. Approximately 46.8% of rexulti® patients and 48.3% of placebo patients had presence of anxiety with a mean madrs score of 26.9 in both the rexulti® 2-mg/day group and the placebo group. These patients also had similar prior failure rates for at least 1 antidepressant and 2 antidepressants. Study 2 data affirm these results..

[Audio] The results of the study demonstrate that madrs scores decreased as treatment progressed in both the placebo and the brexpiprazole groups. In study 2 the 3 milligrams dose was found to be more effective than the placebo at the 6-week endpoint whilst the 1 milligrams dose did not have a meaningful difference from the placebo. In Study 1 when rexulti 2 milligrams was combined with A-D-T it was statistically superior to the placebo plus A-D-T leading to a 8.4 point reduction in the madrs score at the 6-week endpoint..

[Audio] Akathisia was reported by 9% of patients and restlessness by 3% of patients across all doses in studies involving placebo-controlled groups. In the two 6-week studies akathisia was reported in 4% 7% and 14% of patients treated with 1 milligrams/day 2 milligrams/day and 3 milligrams/day of rexulti® respectively while it was reported in only 2% of the placebo plus A-D-T group. Likewise restlessness was observed in 2% 3% and 4% of the 1 milligrams/day 2 milligrams/day and 3 milligrams/day rexulti® groups respectively compared to 0% in the placebo plus A-D-T group. Summarizing rexulti® may be beneficial as an adjunctive therapy for major depressive disorder; however common adverse reactions include akathisia and weight gain..

[Audio] Results from two long-term open-label studies of rexulti® showed that 5.0% of patients with normal fasting glucose levels at baseline experienced a shift to high glucose levels and 25% of patients with borderline fasting glucose levels at baseline experienced a shift to high glucose levels. Atypical antipsychotic drugs have been linked to metabolic changes such as hyperglycemia/diabetes mellitus dyslipidemia and body weight gain so it is important to monitor all patients accordingly..

[Audio] Results of our two pivotal clinical studies indicated that when taken as an adjunctive therapy for Major Depressive Disorder rexulti® (brexpiprazole) had small mean increases in total cholesterol in line with the placebo group's decrease in cholesterol. There were small numerical increases in H-D-L cholesterol at the last visit for both the A-D-T plus brexpiprazole and A-D-T plus placebo groups with some patients experiencing a shift from normal to low H-D-L cholesterol. Mean changes from baseline to last visit in L-D-L and triglyceride levels were variable with increases and decreases observed for the A-D-T plus brexpiprazole groups..

[Audio] Examining the data 9% of patients with normal baseline total cholesterol exhibited shifts to high and 14% of those with normal baseline H-D-L cholesterol witnessed shifts to low. Additionally 17% of patients with normal baseline triglycerides experienced shifts to high while only 0.2% registered shifts to very high.2.

[Audio] Data from Studies 1 and 2 indicate that mean body weight slightly increased with increasing brexpiprazole dose with only two percent of placebo patients experiencing an increase of 7% or more. In long-term open-label studies rexulti was associated with a mean change from baseline of around 3 kilograms of body weight and 30% of patients demonstrated an increase of 7% or more..

[Audio] rexulti® is an adjunctive therapy for major depressive disorder recommended to be taken orally in a dose of 0.5 or 1 milligrams daily with or without food. This dosage can be increased to the target dosage of 2 milligrams once daily in weekly intervals according to the patient’s clinical response and tolerability. The highest recommended daily dose is 3 milligrams making it an effective and comfortable treatment solution for major depressive disorder..

[Audio] We are here to introduce rexulti® (brexpiprazole) as an additional treatment for major depressive disorder approved by the F-D-A for use in adults. rexulti is recommended to be taken alongside an antidepressant. Please note that rexulti has not been shown to be effective in children with depression and should be used with caution in those aged 24 and younger as it can increase the risk of suicidal thoughts and behavior. People close to patients should take note of any changes in behavior and contact their healthcare provider if necessary..

[Audio] rexulti® (brexpiprazole) is an FDA-approved prescription medicine for use as an adjunctive therapy for major depressive disorder. Studies have demonstrated its effectiveness in combination with commonly used antidepressants. Healthcare providers should discuss the possible safety information related to this medication including the increased mortality risk potentially seen in elderly patients with dementia-related psychosis..

[Audio] Concerning rexulti® (brexpiprazole) as an adjunctive therapy for major depressive disorder it is important to be aware of the risks and contraindications associated with it. Hypersensitivity reactions such as facial swelling urticaria and anaphylaxis have been reported. In placebo-controlled trials with risperidone aripiprazole and olanzapine in elderly patients with dementia there was a higher incidence of cerebrovascular adverse reactions including fatalities compared to placebo-treated patients. Neuroleptic Malignant Syndrome a potentially fatal complex has been associated with the administration of antipsychotic drugs. Symptoms of this include hyperpyrexia muscle rigidity altered mental status and evidence of autonomic instability necessitating immediate discontinuation of the medication and medical monitoring and treatment of other conditions..

[Audio] rexulti® is an adjunctive therapy for major depressive disorder. It is important to note that the use of certain antipsychotics may increase the risk of developing Tardive Dyskinesia (T-D---). The risk increases with the duration of treatment and total cumulative dose. Additionally reports of metabolic changes such as hyperglycemia and diabetes may occur in patients taking atypical antipsychotics including rexulti and these should be monitored regularly..

[Audio] rexulti® (brexpiprazole) is an atypical antipsychotic indicated as an adjunctive therapy for major depressive disorder. Possible side effects of this medication include hyperglycemia dyslipidemia weight gain leukopenia neutropenia and agranulocytosis. Individuals with a history of any of these conditions should be closely monitored and all users should have regular check-ups to address any unwanted reactions..

[Audio] rexulti® is an adjunctive therapy for major depressive disorder. However it carries a small risk of orthostatic hypotension and seizures as well as the potential to disrupt the body's ability to regulate body temperature. Therefore caution should be exercised when using rexulti® particularly in those with a history of cardiovascular cerebrovascular or seizure-related conditions. Additionally care should be taken when engaging in strenuous exercise extreme heat taking other medications with anticholinergic activity or when there is a risk of dehydration..

[Audio] When considering taking rexulti it is important to know that potential side effects such as dysphagia and cognitive and motor impairment might occur and that caution should be taken with concomitant medications or alcohol. Patients should speak to their doctor to determine if rexulti is a suitable treatment option for them. Dosage may need to be adjusted when taken with certain medications or when starting or stopping certain medications..

[Audio] rexulti® may be a beneficial supplementary treatment for major depressive disorder. Common side effects include akathisia and weight gain and there is a risk of dystonia developing in some patients. rexulti should not be used during pregnancy or while breastfeeding and a medical professional should be consulted prior to taking the medication..

[Audio] We have discussed the potential of using rexulti® (brexpiprazole) as an adjunctive therapy for major depressive disorder and the important safety information and indications associated with this medication. We hope you have found this presentation informative. Please consult the full prescribing information and contact your doctor for more information if needed. Thank you for your attention..