FDA approves Otsuka/Lundbeck drug for both depression and schizophrenia
- Rexulti (brexipiprazole) has been approved by the FDA for treatment of adults, including use as adjunctive therapy in patients with major depressive disorder (MDD) and montherapy in patients with schizophrenia.
- Rexulti will be co-marketed in the U.S. by Otsuka and Lundbeck.
- The drug is being introduced in August and is considered a successor to Abilify (aripiprazole).
With $6.4 billion in revenues in 2014, Abilify (aripiprazole) was ranked No. 11 in PM Live's Top 50 Pharma List, so introducing Rexulti as a successor to Abilify requires real confidence in the product. Ahead of submitting Rexulti for approval, Otsuka and Lundbeck compiled a sold clinical program, including four phase III, placebo-controlled trials, with a combined total of 4,300 patients. Two studies evaluated use of Rexulti as adjunctive therapy in patients with MDD, while the other two focused on use of Rexulti for schizophrenia monotherapy.
In a six-week MDD study, patients who received Rexulti plus antidepressant therapy (ADT) were compared with patients treated with only ADT. Using the Montgomery-Asberg Depression Rating Scale (MADRS), researchers found that patients treated with 2-mg and 3-mg doses, respectively, had decreases in the MADRS of 8.36 and 8.29, compared with placebo plus ADT. In the placebo group, ADT reductions were 5.15 and 6.33 (in the 2-mg and 3-mg studies, respectively).
In a six-week study of patients with schizophrenia, Rexulti (at 2-mg and 4-mg doses) was evaluated as monotherapy. Using the Positive and Negative Symptom Scale (for schizophrenia), researchers documented decreases in PANSS of -20.73 with 2-mg daily doses and -19.65 with 4-mg daily doses, compared with -12.01 in placebo-treated patients.
Overall tolerability was good, however, weight gain was experienced by at least 4% of Rexulti patients.
The Rexulti team is preparing to launch Rexulti and the market seems ready for a new treatment options for MDD and schizophrenia.