Minerva Entangles in Web of FDA Rejection Again Over Schizophrenia Drug Roluperidone

- Minerva Neurosciences faces a second rejection from the U.S. Food and Drug Administration (FDA) regarding their experimental schizophrenia drug, roluperidone.
- The FDA determined that the clinical trial evidence provided by Minerva was insufficient to establish substantial evidence of effectiveness for roluperidone.
- The agency also identified a lack of data on concomitant antipsychotic administration, clinically meaningful improvements in negative symptoms, and an inadequate number of subjects exposed to the proposed dosage of 64 mg for at least 12 months.

- To move forward, the FDA requests at least one additional "positive, adequate, and well-controlled" study supporting the drug's effectiveness.

- Minerva's CEO, Dr. Remy Luthringer, expressed disappointment and stated they will review the FDA's feedback and consider potential paths forward while working closely with the FDA to provide necessary information for approval.

- Shares in Minerva dropped significantly upon the news, reflecting investor concern.

- Other developments in the field include Karuna Therapeutics' potential approval of a drug for adults with schizophrenia later in 2024.