MDD Archives - Medical Design Sourcing

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…

Pharmacogenomic testing reduced drug-gene interactions in depressed patients

[Image by Holger Langmaier from Pixabay]

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 of care, 18% had no such interactions.

Patients in the trial were selected from Department of Veterans Affairs (VA) medical centers from July 2017 to February 2021.

“From a VA policy perspective, I don’t think that we would say the study is robust enough that we recommend testing everybody,” said Dr. David Oslin, director of VA’s VISN 4 Mental Illness, Research, Education, and Clinical Center (MIRECC). “The results were not a slam dunk, and in fact, an important outcome of the study …

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 patients, according to a description on ClinicalTrials.gov. The trials would focus on studying the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of CYB003 in patients with MDD.

The proposed study would use the Montgomery-Asberg Depression Rating Scale to gauge improvements in mood and other parameters.

Psilocybin has received a growing amount of interest in recent years. The compound is the focus of more than 50 studies, including Phase 2 studies focused on depressive and post-traumatic stress disorders.

Cybin is also investigating the potential of …

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…