Braeburn Pharmaceuticals said yesterday that a 6-month study of its risperidone implant in patients with schizophrenia or schizoaffective disorder met its primary endpoint.
Risperidone, the most commonly-prescribed therapy for schizophrenia, depends on consistent administration, but patients with schizophrenia sometimes stop taking their medication when their symptoms improve. Long-acting, injectable formulations of risperidone are on the market, but there is no FDA-approved formulation that lasts for 6-months, according to Braeburn.
The trial was designed to compare plasma concentrations of risperidone and its active metabolite between the implant, BB0817, and an oral formulation of the drug. The study enrolled more than 50 patients with schizophrenia who were stable on a daily 4 milligram oral dose of risperidone for at least 8 weeks, Braeburn said. Patients recieved 3 implants just under the skin in their upper arm.
The study met its objectives, demonstrating that plasma concentrations of risperidone and its metabolite were comparable and consistent between the implant and the oral formulation.
“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,” president & CEO Behshad Sheldon said in prepared remarks. “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 III 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.”
The Princeton, N.J.-based company also evaluated the safety and efficacy of its implant. Throughout the 6-month trial, 100% of patients remained stable with no clinically significant change in symptoms compared to baseline. Systematic adverse events were similar to those seen with oral risperidone, including akathisia and anxiety.
“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,” principal investigator Dr. Rishi Kakar added. “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.”
In February, Braeburn pulled its plans for a $150 million initial public offering, citing unstable market conditions.
The company 1st announced plans to go public in late December and in mid-January, Braeburn said it planned to raise $150 million by offering 7,692,308 shares of its common stock at $18.00 to $21.00 apiece.