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…
Pharmacogenomic testing reduced drug-gene interactions in depressed patients
A study of 1,944 patients published in JAMA found that pharmacogenomic testing helped to minimize drug-gene interactions in patients with major depressive disorder (MDD) but had little to no effect on symptom remission at 24 weeks. In the randomized trial, 45% of patients who received pharmacogenomic testing had no predicted drug-gene interactions. Of those who received standard…
Cybin files IND with FDA for early human study focused on major depressive disorder
The biopharma Cybin Inc. (NYSEAMERICAN:CYBN) has filed a submission of an Investigational New Drug (IND) application with the FDA for its Phase 1/2a first-in-human clinical trial focused on CYB003. CYB003 is a proprietary psilocybin analog as a proposed treatment of major depressive disorder (MDD) as an adjunct to psychotherapy. The study would enroll approximately 40…
AbbVie touts positive cariprazine data in major depressive disorder
The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in a 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%…
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…
Small Pharma Inc. plans Phase 2b trial of DMT for depression
Small Pharma Inc. (TSXV:DMT) is prepping a Phase 2b clinical study to test the use of its lead candidate, SPL026, an N, N-dimethyltryptamine (DMT) in treating major depressive disorder (MDD). DMT is present in Ayahuasca, a South American psychedelic brew. The company has announced that it has had positive discussions with FDA regarding the planned…