Add-on Vraylar provides new option for treating major depressive disorder

[Cariprazine image courtesy of PubChem]

Traditional antidepressant therapy doesn’t work for all depressed patients. 

About four out of 10 patients see a noticeable benefit from an antidepressant after six to eight weeks, according to Dr. Arif Khan, a board-certified psychiatrist.

For the six out of ten who don’t see a benefit, “the first choice is to switch to a different class of an antidepressant,” said Khan, an adjunct professor of psychiatry at Duke University School of Medicine and the Pacific Northwest University of Health Sciences. “Usually two of the six will benefit,” Khan added. 

Some patients don’t see a tangible benefit after cycling through multiple antidepressants. One challenge is that “there are no widespread and accepted methods about choosing antidepressant medications,” Khan said. 

The treatment landscape for major depressive disorder (MDD) is evolving. In late 2022, AbbVi…

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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…

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AbbVie and Gedeon Richter unveil neuropsychiatric alliance

AbbVie (NYSE:ABBV) and Gedeon Richter have formed a co-development and license agreement focused on novel dopamine receptor modulators with the potential to treat neuropsychiatric diseases.

Lake Bluff, Illinois-headquartered AbbVie and Budapest, Hungary-based Gedeon Richter have already collaborated for 15 years in central nervous system projects, including the development of cariprazine (Vraylar/Reagila), which is now authorized to treat conditions such as schizophrenia and bipolar disorder.

Richter has identified several new chemical entities to pursue with Gedeon Richter and has already performed preclinical research on them.

“In collaboration with Richter, we will continue to build on our research that seeks to provide additional insights into our understanding of cariprazine’s clinical pharmacology and explore novel chemistry to identify new dopamine receptor modulators,” said Tom Hudson, MD, senior vice president, R&D, chief s…

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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 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…

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