cariprazine Archives - Medical Design Sourcing

The future of MDD treatment: A comparative table highlighting the emergence of fast-acting therapies

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The treatment landscape for major depressive disorder (MDD) continues to diversify, and in the coming years, psychedelic options may be available, including COMPASS Pathways COMP360 and the deuterated psilocybin analog CYB003 from Cybin. CYB003 demonstrated a significant -14.08 point reduction in MADRS score, a 53.3% response rate, and a 20% remission rate at a 12mg dose in interim results from its phase 2 study.

The potential of faster-acting more effective therapies

While it is difficult to compare the results from disparate clinical trials, some broad patterns emerge when viewing data from current treatment options and drugs now in clinical development for MDD (see table below). In contrast, newer treatment options, especially psychedelic therapies such as CYB003 and COMP360, demonstrate potentially faster onset and greater magnitude of symptom reduction.

The promise of NMDA and dopamine rec…

Analysis shows that cariprazine may have cost savings potential for treating MDD

[Cariprazine image courtesy of PubChem]

The Vraylar (cariprazine), which recently scored FDA approval as an adjunctive treatment for Major Depressive Disorder (MDD), could have positive implications for healthcare resource utilization. A new analysis suggests that this atypical antipsychotic, initially developed by Allergan (now AbbVie), could curb healthcare spending of MDD treatment.

In the economic analysis, patients who received cariprazine as their first adjunctive therapy had 45% fewer MH-related hospitalizations and 33% fewer outpatient visits per patient-year than those who received it as a subsequent adjunctive therapy. Additionally, patients starting cariprazine as their first adjunctive therapy also had $2,182 lower total MH-related healthcare costs per patient per year. This was largely a result of significantly lower outpatient visit costs, which were reduced by $1,511 per patient per year, relative…

Early data suggest adjunctive cariprazine could be a promising tool for tackling stubborn anhedonia in MDD

[Cariprazine image courtesy of PubChem]

The dopamine D3 receptor-targeting cariprazine could potentially be a new tool for managing anhedonia, one of the most stubborn symptoms of major depressive disorder (MDD). Characterized by a lack of enjoyment in previously pleasurable activities, anhedonia has been “difficult to address with traditional antidepressants,” said Dr. Vladimir Maletic, coauthor of a poster presented at the U.S. Psych Congress annual meeting held earlier this month in Nashville.

In a post hoc analysis focusing on the adjunctive use of AbbVie’s dopamine D-preferring D3/D2 cariprazine in MDD patients with an inadequate response to one to three antidepressant therapies, patients saw a notable improvement in overall depressive symptoms and, specifically, anhedonia symptoms. This improvement, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS), was observable as early as week 2…

FDA approves cariprazine as an adjunctive treatment for major depressive disorder

AbbVie (NYSE:ABBV) has announced that the FDA has approved Vryalar (cariprazine) as an adjunctive therapy to antidepressants to treat major depressive disorder (MDD) in adults.

Cariprazine is a novel atypical antipsychotic drug (APD) that works as a partial agonist at the dopamine D2 and D3 receptors and serotonin 5-HT1A receptors. It works as an antagonist at the 5-HT2B serotonin receptors.

The indication is the fourth for the drug, which first scored FDA approval as an acute schizophrenia treatment and for bipolar disorder in 2015. Two years later, the drug won an indication as a maintenance treatment for schizophrenia. In 2019, cariprazine won expanded use to treat depressive episodes related to bipolar depression in adults.

Cariprazine is the only dopamine and serotonin partial agonist to win FDA approval for MDD and the depressive episodes associated with bipolar I disorder.

Supported by clinical data demonstrating efficacy and well-establis…

AbbVie touts positive cariprazine data in major depressive disorder

The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in the Phase 3 3111-301-001 study involving patients with major depressive disorder (MDD).

AbbVie (NYSE:ABBV) is aiming to win a new FDA indication for the drug as an adjunctive treatment of MDD by the end of the year.

According to MedPage Today, 44% of patients in the 1.5-mg arm had at least a 50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score by week 2 of treatment.

The company did not divulge significant data in a news release, stating that patients receiving a 1.5mg/day dose of the drug met the primary endpoint of statistically significant improvement based on the MADRS at week six compared to placebo. Patients receiving 3.0 mg/day per day had an improved MADRS total score, but the results were not statistically significant.

Patients in the 1.5 mg group also saw improvements in their scores on the Hamilton Depression Rating Sc…

AbbVie files supplemental New Drug Application with FDA for cariprazine

AbbVie (NYSE: ABBV) has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar)for major depressive disorder (MDD).

FDA first approved cariprazine for schizophrenia and bipolar disorder in 2015. Current indications of the drug cover the acute treatment of manic or mixed episodes related to bipolar I disorder and depressive episodes associated with bipolar I disorder.

In its recent sNDA, AbbVie is attempting to secure approval of the drug as an adjunctive treatment with MDD who receive ongoing antidepressants.

Antidepressants are a cornerstone of treating depression, although experts are divided on the efficacy of antidepressants in general. One study published on InformedHealth.org found that antidepressants at large are roughly 20% more effective than placebo in treating depression.

In the submission, AbbVie included data on cariprazine recipients showing clinical improvements based on the Montgomery-Åsberg Depression Ratin…