FDA rejects new drug application for schizophrenia treatment

The FDA has declined to approve a new drug application for roluperidone to treat negative symptoms in individuals with schizophrenia.

According to a press release from Minerva Neurosciences Inc., the FDA, in its Complete Response Letter, said the petition lacked pertinent data on concomitant antipsychotic administration, as well as data required to establish clinically meaningful change in negative symptoms of schizophrenia with roluperidone administration. The FDA additionally cited a lack of substantial efficacy in one study of the drug, along with an inadequate number of participants exposed to roluperidone at the proposed dose of 64 mg for at least 12 months.

“We are disappointed that the FDA has not approved roluperidone and will request a meeting to discuss the issues raised and attempt to address FDA’s feedback,” Minerva CEO Remy Luthringer, PhD, said in the release. “We believe that roluperidone is a safe and effective therapy for negative symptoms of schizophrenia and we will review FDA’s feedback and consider our potential paths forward, including continuing to work closely with the FDA and providing any additional information as needed.”

Minerva will be required to submit at least one additional positive, adequate and well-controlled study to support safety and effectiveness of roluperidone, in addition to clinically meaningful data supporting safety and efficacy of the drug when co-administered with antipsychotic medications and evidence of long-term safety at the proposed dose.