Long-acting injectable (LAI) formulations of antipsychotics to treat patients diagnosed with schizophrenia remain under-utilized in the seven major markets (7MM*) due to the resistance surrounding the use of these products despite the benefits, says GlobalData, a leading data and analytics company.

According to GlobalData, patients tend to continue oral antipsychotic treatment, and this results in a lower than anticipated uptake of LAIs, which are injected every fortnight or in one-to-six month intervals. The discontinuation of or non-adherance to antipsychotic treatment is the most common cause of relapse in patients diagnosed with schizophrenia.

A recent survey** by GlobalData reveals that the prescription of daily oral aripiprazole, one of the most commonly used atypical antipsychotics, continues to dominate over the use of Otsuka and Lundbeck’s once-monthly LAI formulation Abilify Maintena and Alkermes’ Aristada, which can be administered every six weeks.

This trend was particularly significant in Japan and Germany with 90.2% and 82.7% of patients using oral aripiprazole, respectively. However, there was a significant variability across the 7MM with LAI aripiprazole usage in Spain and the UK reaching 45.4% and 47.5%, respectively. Overall, throughout the 7MM, the vast majority (70.2%) of patients receiving aripiprazole in 2021 were prescribed the oral formulation.

Christie Wong, Pharma Analyst at GlobalData comments: “Patients diagnosed with schizophrenia are typically offered continuous antipsychotic pharmacotherapy to prevent recurring episodes of psychosis. Those who have a history of good response to oral antipsychotics but have adhered poorly to the treatment regimen, resulting in relapse, are eligible to receive LAI therapy. These products provide an efficient method for monitoring treatment adherence, as they must be administered in a clinical setting, allowing for appointment attendance to be tracked.

“In fact, some key opinion leaders (KOLs) interviewed by GlobalData argued that LAIs should be prescribed even sooner, following first episode psychosis or during early-stage schizophrenia. These experts reasoned that the majority of patients could benefit from the improved adherence and relapse prevention offered by the LAIs. However, despite these benefits, these therapies remain underutilized.”

There are many reasons for lingering resistance around the use of LAIs over oral antipsychotics, with individual preferences from both patients and psychiatrists. For example, there are concerns regarding the long wash-out period for LAIs and the management of the side effects that are common with antipsychotic treatment. Furthermore, the administration of LAI antipsychotic treatment requires a healthcare professional and does not appeal to patients with needle phobia.

Wong continues: “KOLs noted that in an outpatient setting, many psychiatrists are ill-equipped to administer these injectables. This was particularly evident in clinics and practices where they do not have a nurse on staff and the psychiatrist is uncomfortable giving routine injections. Unfortunately, this can cause a barrier to the widespread adoption of LAIs as a standard of care for patients with schizophrenia.”

Over the past decade, the development of LAI antipsychotic treatments has been a popular research and development (R&D) strategy for pharma companies. With the anticipated patent expiry of Abilify Maintena in the 5EU* and US in 2023 and 2024, respectively, Otsuka and Lundbeck look to launch their next-generation aripiprazole reformulation, a LAI dosed once every two months. GlobalData forecasts that the aripiprazole two-month LAI will launch in the US and 5EU in 2023.

Wong adds: “Based on discussions with KOLs, the uptake of the aripiprazole two-month LAI is anticipated to be limited as the market is crowded with LAIs and generally the implementation of LAIs within a standard of care for schizophrenia remains low: on average there were less than 30% of aripiprazole prescriptions in the 7MM in 2021, according to GlobalData’s research.

“Regarding ways to improve the uptake of LAI products, KOLs touted that the expansion of the administration possibilities to pharmacies and to nurses outside the psychiatric team could improve access to LAI products and be particularly beneficial to outpatients.”

*7MM: The US, Japan and 5EU (France, Germany, Italy, Spain, the UK)

**2022 Schizophrenia high prescriber survey: GlobalData surveyed 84 high-prescribing psychiatrists, who represented the 7MM. The survey was launched in and completed in June 2022.