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Aripiprazole once-every-two-months long-acting injectable gains EU approval for schizophrenia

The once-every-two-months long-acting injectable (LAI) aripiprazole 960 mg (brand name Abilify Maintena) has been approved by the European Commission (EC) for the maintenance treatment of schizophrenia, its manufacturer Otsuka Pharmaceutical has announced.

It is indicated for adult patients with schizophrenia who have been stabilised with aripiprazole and is the first once-every-two-months LAI antipsychotic licensed in the EU for this indication.

Aripiprazole once-every-two-months LAI is a dopamine D2 partial agonist and 5-HT1A partial agonist and a 5-HT2A receptor with antagonistic activity.

It is provided in a single-chamber prefilled syringe that does not require reconstitution and is administered via intramuscular injection into the gluteal muscle.

Aripiprazole is also available as a daily oral tablet, orally disintegrating tablet, oral solution, a short-acting intramuscular injection (brand name Abilify), or a once-monthly LAI formulation (Abilify Maintena 400 mg).

Dr Peter Gillberg, vice president and head of medical affairs at Otsuka Europe, said: ‘We welcome the EC approval of aripiprazole once-every-two-months LAI, which represents a significant milestone in offering adult patients with schizophrenia another, simplified, treatment regimen.

‘We hope that this treatment may help to mitigate challenges with adherence, and potentially allow patients and their healthcare practitioners to focus on other elements of care.’

Dr Johan Luthman, executive vice president and head of research and development at Lundbeck, which co-developed and is co-commercialising the treatment, echoed these points, referring to the approval as an ‘important step for patients, families, and healthcare providers’.

He added: ‘Specifically designed for adult patients with schizophrenia who have been stabilised with aripiprazole, this treatment aims to increase patient adherence and convenience, contributing to the careful and comprehensive management of this chronic condition.’

Efficacy, safety and tolerability of aripiprazole

The EC approval of aripiprazole once-every-two-months LAI is based on a 32-week pharmacokinetic bridging trial, which also evaluated the safety and efficacy of the drug as primary and secondary endpoints respectively.

Of the 266 participants enrolled (schizophrenia, n = 185; bipolar I disorder, n = 81), 132 were randomised to receive aripiprazole once-every-two-months LAI (Ari 2MRTU 960) and 134 to receive aripiprazole once-monthly LAI (AOM 400).

The study completion rate was 77.3% in the Ari 2MRTU 960 group and 68.7% in the AOM 400 group.

The geometric means ratio (GMR) of aripiprazole plasma concentrations on the last day following the final dosing for Ari 2MRTU 960 versus AOM 400 was 1.011 (90% confidence interval [CI] 0.893–1.145), and the GMR of aripiprazole plasma exposure (area under the concentration–time curve) over the fourth Ari 2MRTU 960 dosing interval versus the seventh and eighth AOM 400 dosing intervals was 1.006 (90% CI 0.851–1.190).

The most frequently reported treatment-emergent adverse events were increased weight (Ari 2MRTU 960: 22.7%; AOM 400: 20.9%) and injection-site pain (Ari 2MRTU 960: 18.2%; AOM 400: 9.0%).

The researchers concluded that the aripiprazole once-every-two-months LAI was shown to provide similar plasma concentrations, and therefore similar effectiveness, as well as a similar safety and tolerability profile to aripiprazole once-monthly LAI in adults with schizophrenia.

In December, the Medicines and Healthcare products Regulatory Agency issued a reminder to healthcare professionals involved in the prescribing of aripiprazole for schizophrenia and bipolar disorder to be alert to the known risk of patients developing addictive gambling.

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