BB0817, a 6-month risperidone implant, had comparable efficacy, safety and tolerability with oral risperidone, according to findings released by Braeburn Pharmaceuticals.
“Schizophrenia is a potentially devastating disease, but it can be well-managed through compliance with antipsychotic medication. BB0817 may provide a compelling option to help patients manage schizophrenia, consistent with Braeburn’s commitment to develop long-acting implantable and injectable treatments for stigmatized diseases where adherence is critically important,” Behshad Sheldon, BS, president and CEO of Braeburn Pharmaceuticals, said in a press release. “This clinical program in schizophrenia represents a strong complement to our initial therapeutic focus in addiction and pain. Looking ahead, we expect results from a phase 3 risperidone safety study later this year and are targeting a year-end 2017 filing of a New Drug Application seeking approval for the risperidone implant.”
To determine safety, tolerability and pharmacokinetics of BB0817 for schizophrenia, researchers conducted a phase 2/phase 3 study comparing average plasma concentrations of risperidone and 9-hydroxy-risperidone between the implant and oral risperidone among 50 individuals. Study participants, diagnosed with schizophrenia or schizoaffective disorder, were stable on 4 mg of oral risperidone. Participants received three risperidone implants in their upper arm.
Plasma concentrations of oral risperidone and 9-hydroxy-risperidone were comparable to plasma levels of BB0817. This remained consistent throughout the 6-month study, according to researchers.
From baseline to 6 months, all participants remained stable with no clinically meaningful changes in Positive and Negative Symptom Scale scores.
Systemic adverse events included akathisia (9%), extrapyramidal side effects (6%) and anxiety (6%).
The most common treatment-emergent adverse event was implant site pain (11%), which was generally reported as mild, according to researchers.
Ninety-four percent of participants who had the opportunity to enroll in an extension phase chose to receive a second set of implants.
“Compliance with medication is a very important clinical issue, and without it, serious consequences including relapse and hospitalization are more likely. Preventing non-compliance is an important goal for any successful clinical treatment. The 6-month risperidone implant, if approved, would offer physicians and patients an innovative approach to the treatment of schizophrenia,” study researcher Rishi Kakar, MD, of the Segal Institute for Clinical Research in Miami, said in the release. “The implant is administered through a short, in-office procedure, and provides a treatment duration that is more than twice as long as currently-marketed injectables.”