FDA accepts NDA for 2-month injectable to treat schizophrenia, bipolar disorder in adults

The FDA has accepted a new drug application for aripiprazole, a 2-month, ready-to-use, long-acting injectable for the treatment of schizophrenia in adults and maintenance monotherapy treatment of bipolar I disorder in adults.

The announcement was made in a joint press release issued by Otsuka America Pharmaceutical Inc. and H. Lundbeck A/S. According to the release, aripiprazole is provided in 720 mg and 960 mg single-chamber-type, prefilled syringes with recommended administration every 2 months via injection into the gluteal muscle.

Results from clinical trial 031-201-00181, which enrolled 266 patients, demonstrated that 960 mg aripiprazole long-acting injectable achieved similar plasma concentrations and thus comparable effectiveness to 400 mg aripiprazole once-monthly over a two-month period, the companies said in the release.

The companies further stated that multiple-dose administrations of 960 mg aripiprazole 2-month, long-acting injectable were generally safe and well tolerated in patients with schizophrenia or bipolar I disorder, with no new safety concerns compared with once-monthly 400 mg aripiprazole.

“This is an important milestone in our efforts to offer adult patients with schizophrenia or bipolar I disorder a new option designed to support treatment goals and offer greater flexibility,” Johan Luthman, executive vice president of Lundbeck Research & Development, said in the release. “The trial results reinforce the long-standing efficacy and safety profile of the once-monthly, aripiprazole long-acting injectable.”

According to the release, regulatory approval would be based on completion of a multiple-dose, randomized, parallel-arm clinical trial to assess safety, tolerability and pharmacokinetics in adults with schizophrenia or bipolar I disorder. The FDA target date for completion of the review is April 27, 2023.

“Stability is critical for patients with schizophrenia and bipolar I, which means delaying time to relapse or recurrence and supporting their role as functioning members of their community,” Robert McQuade, PhD, executive vice president and chief strategy officer at Otsuka, said in the release. “As we continue our efforts to bring aripiprazole 2-month to market, we remain committed to our patients and confident that the favorable safety and tolerability profile will be clearly visible.”