RBP-7000, a new pipeline drug developed by Indivior for the treatment of schizophrenia, has the potential to benefit patients who have previously demonstrated, or are at a high risk of, non-compliance, according to research and consulting firm GlobalData.
As explored in the company’s most recent schizophrenia report, antipsychotic products currently on the market for the treatment of schizophrenia are effective in managing the positive symptoms of the disorder, but there are still significant unmet needs for the effective control of negative symptoms and for drugs with greater compliance.
On 13th March 2017, Indivior announced that RBP-7000 had positive topline data in a Phase III trial for the treatment of schizophrenia. RBP-7000 is a novel sustained-release product using the ATRIGEL delivery system for subcutaneous administration of risperidone once a month. The data 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 with the FDA last quarter of 2017, giving RBP-7000 an anticipated launch date of Q4 2018.
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 of the US, France, Germany, Italy, Spain, the UK, 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, such as risperidone ISM by Laboratorios Famaceuticos Rovi and BB-0817 by Braeburn Pharmaceuticals.
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, as the increased price of the therapy compared to other generic schizophrenia drugs may prevent it from gaining a significant market share.
Filed Under: Drug Discovery