Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Otsuka, Lundeck Monthly Abilify Approved in Europe | Contract Pharma

What are you searching for?

Sign in
Trials & Filings

Otsuka, Lundeck Monthly Abilify Approved in Europe

IM injection cleared for maintenance treatment of schizophrenia

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Otsuka Pharmaceutical and H. Lundbeck A/S has received marketing authorization approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

According to the companies, Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia. It has a tolerability profile similar to oral aripiprazole and demonstrated statistically significant benefits on patients’ personal and social functioning as compared to placebo.

The efficacy of Abilify Maintena was demonstrated in two double-blind, Phase III, randomized trials. The safety profile for Abilify Maintena was demonstrated to be similar to that of oral Abilify. The most frequently observed adverse drug reactions (ADRs) reported in ≥5 percent of patients in two double-blind controlled clinical trials of Abilify Maintena were weight increases (9.0%), akathisia (7.9%), insomnia (5.8%), and injection site pain (5.1%).

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics