FDA Accepts Alkermes' NDA For Schizophrenia Drug
By C. Rajan, contributing writer
The U.S. FDA has just accepted for filing Alkermes’ New Drug Application (NDA) for aripiprazole lauroxil, a novel once-monthly injectable antipsychotic for the treatment of schizophrenia. FDA action on the NDA is expected by Aug. 22, 2015.
“The FDA acceptance of the aripiprazole lauroxil NDA marks the achievement of an important milestone for this program and brings us another step closer to offering patients and physicians a new treatment option for schizophrenia with distinctive features, including a range of doses and ready-to-use format,” stated Richard Pops, CEO of Alkermes. “If approved, aripiprazole lauroxil could be a significant new entrant in the increasingly important category of long-acting injectable medicines for schizophrenia.”
Alkermes submitted the NDA for the once-monthly formulation of aripiprazole lauroxil in August, based on positive results from the phase 3 study assessing the efficacy and safety of aripiprazole lauroxil. In the multicenter, placebo-controlled phase 3 study, two doses of aripiprazole lauroxil, 441 mg and 882 mg, were administered once monthly, and both doses met the primary and secondary endpoints. The drug demonstrated significant improvements in schizophrenia symptoms, compared to placebo. Aripiprazole lauroxil was also well tolerated in the study and showed a safety profile similar to that reported with oral aripiprazole.
The active ingredient, aripiprazole, is a dopamine D2 partial agonist and is one of the most commonly used oral antipsychotic medications. Oral aripiprazole is marketed under the name Abilify by Otsuka Pharmaceutical and Lundbeck and received FDA approval in February 2013. Since its launch in the U.S., Abilify, a once daily tablet, became the best-selling drug in 2013 with sales of nearly $6.5 billion.
Alkermes’ drug, aripiprazole lauroxil, is formulated as a long-acting injectable (LAI) which gradually converts into aripiprazole in the body, and is being developed by Alkermes as both one-month and two-month injectable options. The recent NDA submission is for the one-month formulation, while the two-month formulation will be in clinical trials this year. According to Alkermes, aripiprazole lauroxil will have multiple dosing options administered in a ready-to-use, pre-filled product format.
Alkermes’ long acting antipsychotic formulation is expected to help schizophrenia patients considerably, as patient compliance with the daily oral medications is one of the major problems in treating this condition. Schizophrenia is a serious mental illness which is marked by hallucinations, depression, and disorganized thinking. According to Alkermes' press release, an estimated 2.4 million American adults have schizophrenia, and about one person in every 100 develops schizophrenia globally.