FDA Approves Aripiprazole As A Once A Month Treatment for Schizophrenia


AripiprazoleAs a blockbuster medication used to treat schizophrenia, Aripiprazole CAS# 129722-12-9 has recently been approved by the FDA as a once a month treatment. Marketed by Otsuka and Bristol-Myers Squibb, this monthly dosage of aripiprazole will be sold under the name Abilify Maintena. Aripiprazole is a solid and reliable long-acting antipsychotic medication, and this FDA approval is momentous to the 1.1 percent of the U.S. population suffering from this devastating mental illness.

Patients with schizophrenia will benefit greatly from this easy to administer once a month dose of aripiprazole. However, other conditions are also successfully treated with aripiprazole. Known as the brand name Abilify, aripiprazole is an antipsychotic medication that is used to treat bipolar disorder, which is also known as manic depression, major depressive disorder in adults alongside antidepressant medications, and as a treatment option for autistic children who are ages 6 and older for symptoms of aggression, irritability, mood swings, and self-injury related to their autistic disorder.  Aripiprazole works by changing the actions of chemicals in the brain. Treatment with aripiprazole should not to be used for patients with psychotic conditions related to dementia, as it may cause these this patient population extreme harm, such as heart failure, pneumonia, or even sudden death.  Less serious adverse effects of aripiprazole may include anxiety constipation, dizziness, drowsiness, headache, upset stomach, weakness and weight gain.

The approval of the once a month treatment for schizophrenia by the FDA on February 28, 2013 is novel as this is the first dopamine D2 partial agonist approved as a once a month injection.  The advent of this unprecedented treatment addresses the ongoing need for relapse prevention in patients with this life altering mental illness. Aripiprazole, or Abilify Maintena, proved to be extremely effectual in a 52-week study. The aforementioned study was placebo-controlled, double-blind, and randomized-withdrawal. As a Phase 3 maintenance trial, Abilify Maintena {aripiprazole} evaluated the time to relapse as the primary endpoint.  269 adult patients who received the once a month dosage had significantly delayed time to relapse as compared to 134 adult patients who received a placebo. In addition, a key secondary endpoint was met, in terms of the percentage of patients who experienced a relapse or exacerbation of psychotic symptoms. Patients who were administered Abilify Maintena had a sharply lower relapse rate of 10 percent as compared to the placebo group who had a 40 percent relapse rate.  With an estimated 24 million people diagnosed with schizophrenia worldwide, fresh treatment options like aripiprazole as a monthly maintenance injection is welcomed by both patients and practitioners.

LGM Pharma offers API Aripiprazole, CAS number 129722-12-9, as well as the TEVA API Aripiprazole for research and development purposes. Clients can be assured of quality products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

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