Expert Insights: Indivior Looking for Approval after Positive Topline Data in Phase III Schizophrenia Trial

27th July 2017 (Last Updated July 16th, 2018 11:14)

GlobalData explore the implications of Indivior’s schizophrenia trial after it revealed positive results from a Phase III study

Expert Insights: Indivior Looking for Approval after Positive Topline Data in Phase III Schizophrenia Trial

Indivior, a specialty pharmaceutical business, has announced that its late stage pipeline drug, RBP-7000, had positive topline data in a Phase III trial for the treatment of schizophrenia. The trial was designed to evaluate the long term safety, efficacy, and tolerability of a monthly depot injection of risperidone. The data readout showed that, in 500 patients over a 12 month period, there were no new safety issues and patients “remained stable or improved” over the test period. On the back of these results, Indivior is aiming to file a New Drug Application (NDA) with the FDA in the last quarter of 2017, giving RBP-7000 an anticipated launch date of Q4 in 2018.

Schizophrenia is a heterogeneous behavioral and cognitive syndrome involving current or recurrent psychosis; it affects an estimated 23 million people globally. The disorder is characterized by positive symptoms (hallucinations, delusions, and disorganized speech), negative symptoms (flat affect and poverty of speech), and cognitive deficits (attention, memory, and executive functions). Antipsychotic products currently on the market for the treatment of schizophrenia are effective in managing the positive symptoms of the disorders, but there are still significant unmet needs for the effective control of negative symptoms and for drugs with greater compliance.

RBP-7000 is a novel sustained-release product using the ATRIGEL delivery system for subcutaneous administration of risperidone once a month. The delivery device consists of a two-syringe system; the contents of these syringes are mixed (one containing the ATRIGEL delivery system and the other containing risperidone) before being administered into the abdomen of the patients. Upon entry to the body, it will solidify, resulting in prolonged release for one month before eventually biodegrading.

Risperidone was originally marketed as Risperdal by Janssen Pharmaceuticals and is currently available as two formulations. The oral formulation, which is administered daily, is widely genericized throughout the seven major markets (7MM: U.S., France, Germany, Italy, Spain, the U.K., and Japan), and the long-acting injectable formulation, Risperdal Consta, administered once every two weeks.

While these provide effective control over schizophrenia symptoms, their compliance rates are poor. RBP-7000 looks to improve the compliance rate in schizophrenia sufferers by reducing the dosing to once a month, meeting a significant unmet need in the market. However, there are other risperidone reformulations in the late stage pipeline that also look to address patient compliance; particularly risperidone ISM by Laboratorios Farmaceuticos Rovi (once monthly administration) and BB-0817 by Braeburn Pharmaceuticals (a six-month implant).

If approved, GlobalData expects that RBP-7000 will be reserved for patients who have previously demonstrated, or are at a high risk of, non-compliance, and who have demonstrated adequate efficacy and tolerability with other risperidone formulations. While risperidone is a well-established drug for the treatment of schizophrenia, Indivior may face difficulty in commercializing RBP-7000 in this highly crowded market.

The increased price of therapy of RBP-7000 compared to other risperidone formulations and other generic schizophrenia drugs may prevent this product from gaining a significant market share. Additionally, the introduction of Braeburn Pharmaceuticals’ six-monthly risperidone implant and Rovi’s once-monthly risperidone ISM system will also directly compete for patient share, if approved. In order to reach its maximum potential, Indivior will therefore need a strong marketing strategy for its product.