Lundbeck's Aripiprazole Beats Competition In Novel Head-to-Head Study
By C. Rajan, contributing writer
Danish biotech firm Lundbeck and its partner Otsuka have announced the positive results from a first-of-its-kind study of their schizophrenia drug aripiprazole (Abilify Maintena), which was pitted up against Janssen’s paliperidone palmitate (Invega Sustena).
The 28-week, randomized, open-label, QUALIFY study compared the effectiveness of aripiprazole once-monthly extended-release injectable suspension and paliperidone palmitate extended-release injectable suspension in 295 adult patients with schizophrenia. The patients received either intramuscular aripiprazole once-monthly or intramuscular paliperidone palmitate, after a three-week oral conversion period when patients received either oral aripiprazole or oral paliperidone.
The drug efficacy was measured by the Heinrichs-Carpenter Quality of Life Scale. The results showed that patients treated with aripiprazole once-monthly showed superior improvement in the quality of life scores compared to those treated with paliperidone palmitate, with a difference in QLS scores of 7.5 for aripiprazole vs. 3.1 for paliperidone.
Secondary assessments such as symptom severity and treatment response indicators also confirmed the superiority of aripiprazole.
The study was designed to test superiority if non-inferiority of the drugs was confirmed. The study design was presented last year at the New Clinical Drug Evaluation Unit 53rd Annual Meeting. The companies also said that these results from the QUALIFY study will be presented at upcoming medical congresses and in scientific publications.
Schizophrenia is a serious mental illness marked by hallucinations, depression, and disorganized thinking. An estimated 24 million people worldwide, and approximately 2.4 million adults in the U.S, suffer from schizophrenia. While the condition cannot be completely cured, the symptoms can be effectively managed with antipsychotic drugs.
Abilify Maintena, an atypical antipsychotic, is a long acting intramuscular injection which makes patient adherence easier. The active ingredient, aripiprazole, is a dopamine D2 partial agonist which works through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors.
Abilify received U.S. FDA approval in February 2013. The drug has also been approved in Europe, Canada, and Australia for the maintenance treatment of schizophrenia in stabilized adult patients. Since its launch in the U.S., Abilify Maintena, a once-monthly injection, became the best-selling drug in 2013 with sales of nearly $6.5 billion.