May 17, 2017
By Christos Michaelides, BioSpace.com Contributor
In April 2017, Braeburn Pharmaceuticals reported that BB0817, a six-month risperidone implant, successfully met its primary endpoint in a Phase II/III safety and tolerability clinical study in schizophrenia patients. The study demonstrated that schizophrenia patients can be safely transitioned from stable oral risperidone treatment onto BB0817.
With an ongoing Phase III efficacy study due to complete later this year and an aim for New Drug Application (NDA) filing by the end of 2017, Braeburn Pharmaceuticals remains on the heels of competitor companies developing other long-acting risperidone treatments for schizophrenia patients.
This positive data reported by Braeburn Pharmaceuticals for BB0817 comes just a few weeks after Indivior Pharmaceuticals reported positive topline data from its Phase III trial of RBP-7000, a monthly depot injection of risperidone. Indivior Pharmaceuticals has also stated its aim for an NDA filing by Q4 2017, which puts both formulations up for approval around the same time.
In addition to these two products, a once-monthly risperidone in situ microparticles (ISM) system is in Phase III development by Laboratorios Farmaceuticos Rovi (Rovi). This formulation, however, is not expected to launch until 2019.
Risperidone is one of the most widely-used antipsychotics for schizophrenia treatment; however, patient compliance is one of the most significant unmet needs in the schizophrenia market. As such, longer-acting formulations of risperidone have been developed, with Risperdal Consta already approved as a two-week, long-acting injectable formulation of risperidone. More recently, however, companies have sought to develop longer-acting formulations of risperidone in order to reduce the dosing frequency further, to improve compliance rates.
Key opinion leaders (KOLs) interviewed as part of GlobalData’s schizophrenia report were positive about all three of the new formulations to improve compliance of risperidone treatment in the schizophrenia market. While Braeburn Pharmaceuticals’ BB0817 has a clear advantage in its treatment duration of six months compared with the once monthly formulations of either Indivior Pharmaceuticals’ RBP-7000 or Rovi’s risperidone ISM system, KOLs highlighted that there is still a great deal of uncertainty regarding the willingness of schizophrenia patients to accept an implant. The current study may begin to address some of these concerns, however; of trial patients that were given the opportunity to enroll in an extension phase for BB0817, 94 percent were reported to have chosen to receive a second set of implants.
Ultimately, the decision to be treated with a six-month implant or one-month injectable will likely come down to patient or physician personal preference, as well as the cost of therapy. It is expected that the six-month BB0817 implant may command a higher price due to its substantially reduced dosing frequency compared with other formulations of risperidone. However, a higher cost may necessitate physicians to provide additional justification for its use, which may push patient share towards cheaper alternatives, including the one-month injectable formulations. In any case, all of the companies aiming to enter this space will require strong marketing strategies, not only to effectively compete with each other but also to convince physicians that these products offer substantial benefits compared with the much cheaper generic oral risperidone.
Christos Michaelides, PhD, is a Neurology and Ophthalmology Healthcare Senior Analyst at GlobalData in London. Prior to working at GlobalData, Christos completed a PhD in Neuroimaging from King’s College London.
