Following the news that Janssen has submitted a Marketing Authorisation Extension to the European Medicines Agency (EMA) for its product paliperidone palmitate 6-Monthly (PP6M) for the treatment of schizophrenia in adults;

Alessio Brunello, Managing Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“Antipsychotic medication are the most prescribed in schizophrenia, however, compliance to these prescribed medicines is very low. Many versions of extended release paliperidone palmitate are approved globally and GlobalData forecast global sales of the drug to reach $5.3bn in 2026.

“GlobalData has identified an unmet need in the schizophrenia market for drugs aimed at increasing compliance. Compliance remains a major issue in schizophrenia, as key opinion leaders (KOLs) explained that when patients begin to feel better, they tend to stop taking their medication. Due to the challenges of maintaining medication adherence in patients with schizophrenia, long-acting injectable (LAI) drugs are becoming an increasingly popular means of drug delivery, based on the theory that a reduced dosing frequency will allow for a reduced administration burden and achieve better rates of adherence. Patients who are non-adherent are over 10 times more likely to relapse and four times more likely to require hospitalization than patients who are adherent.

“PP6M could have an advantage and likely fulfil a sizeable portion of this unmet need as, if approved, PP6M will be the first long-acting injectable schizophrenia treatment with a twice-yearly dosing regimen. Furthermore, KOLs mentioned that drugs with a longer duration of action would increase compliance, while also having an enhanced safety profile and/or improved efficacy.

“LAIs are becoming an increasingly popular choice and are being increasingly prescribed by KOLs due to the vastly increased compliance rates compared to oral dosing. In the past years, pharma companies have increasingly focused on LAI formulations of antipsychotic drugs; as such, this segment has provided significant sales growth, but is also becoming more and more competitive. As the LAI market continues to expand, novel LAI drugs will need to offer a significant advantage over the currently available LAIs.”