Janssen has revealed that Trevicta – its extended-release atypical antipsychotic drug – has received marketing authorization by the European Commission (EC) on May 31 2016. The EC’s decision on Trevicta, developed for the maintenance treatment of schizophrenia in adult patients, comes on the back of an April 2016 recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Janssen’s success in the antipsychotic drug market is largely owed to a successful lifecycle management strategy, as showcased by the development of Invega (oral extended-release paliperidone), as well as its follow-up brand Invega Sustenna (paliperidone once-monthly long-acting injectable [LAI]) – marketed as Xeplion in Europe. In June 2015, this franchise was expanded with the launch of Invega Trinza in the US (known as Trevicta in Europe). Additionally, Trevicta/Invega Trinza contains the active ingredient paliperidone palmitate, and is administered to patients once every three months as an intramuscular injection, making the first and only four-times-a-year treatment for schizophrenia patients.
Compliance is a very common issue in schizophrenia patients and has been identified by GlobalData as a critical unmet need within this market. Poor patient compliance to schizophrenia medication occurs due to a multitude of reasons including, but not limited to, patients’ refusal of treatment as they struggle to accept their illness, patient questioning of the risk-benefit ratio of prescribed therapies, and residual hallucinations or delusions experienced by patients that may "convince" them to stop taking their medication. Non-adherence to maintenance treatment for schizophrenia is the most common cause of relapse in patients, resulting in breakthrough psychotic episodes. Longer-acting antipsychotic medications reduce the frequency of drug administration, and therefore these can offer an effective way of improving patient compliance. This strategy has been sought by several pharma companies over the years, resulting in the development of numerous LAI formulations of antipsychotic drugs, including Otsuka ‘s Abilify Maintena and Janssen’s Risperdal Consta as well as Invega Sustenna/Xeplion. In addition to increasing patient compliance, LAIs are also ideal for patients who display symptomatic behaviors with highly adverse consequences (for example, arrests, assaults, self-harm, or loss of employment). An LAI formulation may also be beneficial in patients who respond well to oral treatment but experience dose-dependent adverse events, as long-acting formulations are associated with more consistent drug plasma concentrations.
Primary research undertaken by GlobalData has revealed that the antipsychotic LAIs are often favored over the oral alternatives by physicians, particularly in cases where patients have previously demonstrated poor compliance to oral formulations. Following its approval, Trevicta is now the antipsychotic with the longest dosing interval available in the European market for the treatment of schizophrenia. GlobalData anticipates that the launch of Trevicta in Europe will increase Janssen’s revenue from the paliperidone franchise in the schizophrenia market. This is largely because patients are expected to switch from its predecessor Xeplion to the newer product Trevicta, which offers fewer doses, in addition to patients switching from other antipsychotics that require more frequent administration.
Three products in the schizophrenia late-stage pipeline are reformulations of risperidone that, similarly to Trevicta, hope to increase patient compliance by reducing the dosing frequency compared to the currently available formulations of the active ingredient. These are Indivior ‘s RBP 7000 and Laboratorios Farmaceuticos Rovi ‘s risperidone in situ microparticles (ISM), both of which are once-monthly formulations, and Braeburn ‘s risperidone implant, which is to be administered every six months. Based upon the locations at which the clinical trials are being conducted for Braeburn’s six-monthly risperidone implant, GlobalData does not anticipate the launch of this product in Europe throughout the 10-year forecast period of its upcoming report PharmaPoint: Schizophrenia – Opportunity Analysis and Forecast to 2025. GlobalData does not expect that Indivior’s RBP 7000 will launch in Europe, for the same reason as Braeburn’s implant, but anticipates the launch of Rovi’s risperidone ISM into the European market in Q4 2020. Therefore, this leaves considerable time for Trevicta to become established in the treatment algorithm for adult schizophrenia patients. As Trevicta will be dosed just four times per year, GlobalData expects Janssen to maintain its edge over the competition thanks to Trevicta, which will remain the antipsychotic with the longest dosing interval for the treatment of schizophrenia within this market.