On 4 December, Janssen submitted a Marketing Authorization Extension Application to the European Medicines Agency (EMA) for its product, paliperidone palmitate 6-monthly (PP6M) for the maintenance treatment of schizophrenia in adult patients who are clinically stable on paliperidone palmitate 1-monthly (PP1M) or 3-monthly (PP3M) injectable products.
Paliperidone palmitate is an atypical antipsychotic drug indicated for the treatment of schizophrenia in adults. Although the drug’s mechanism of action in schizophrenia has not yet been fully elucidated, its therapeutic efficacy is believed to be mediated via antagonism of the D2 and 5-HT2A receptors.
PP6M was studied in a randomised, double-blind, non-inferiority Phase III global study that enrolled 702 adults living with schizophrenia from 20 countries, including European countries. The results showed that 81.3% of patients completed the 12-month, double-blind phase without a relapse event. They also showed that PP6M’s efficacy was non-inferior compared to the efficacy PP3M, as measured by the primary endpoint of time to relapse at the end of the 12-month period. Additionally, the results confirmed PP6M’s safety profile, as seen in previous studies of PP1M and PP3M, and no new safety signals emerged.
Antipsychotic drugs are the most prescribed medications in schizophrenia, but compliance to these prescribed medicines is very low. Many versions of extended release paliperidone palmitate are approved globally. GlobalData forecasts PP6M’s global sales to reach $5.3B in 2026.
One unmet need identified by GlobalData in the schizophrenia market is drugs aimed at increasing compliance. Compliance remains a major issue in schizophrenia, according to key opinion leaders (KOLs) interviewed by GlobalData. When patients begin to feel better, they tend to stop taking their medication, KOLs said. 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 will 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 hospitalisation than patients who are adherent.
If approved, PP6M will have an advantage in this space and will likely fulfil a sizeable portion of this unmet need as it will be the first LAI schizophrenia treatment with a twice-yearly dosing regimen. KOLs noted 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 a more popular choice and are being increasingly prescribed by KOLs due to their better compliance rates compared to oral dosing. Recently, pharma companies have become more focused on LAI formulations of antipsychotic drugs. As such, this segment has provided significant sales growth but is also becoming more competitive. As the LAI market continues to expand, novel LAI drugs will need to offer a significant advantage over the currently available LAIs in order to gain market share.