Johnson & Johnson’s hopes of getting a new schizophrenia drug onto the market have received a setback with the news that US regulators have asked for more information on the treatment.

The US Food and Drug Administration has issued a complete response letter saying it wants additional data before it will approve the company’s New Drug Application for paliperidone palmitate. The investigational once-monthly atypical antipsychotic intramuscular injection was filed as a treatment for schizophrenia and preventing recurrence of its symptoms in October last year.

J&J said that it is reviewing the letter and will work with the FDA to address outstanding issues. It gave no details as to what those issues are but noted that the agency does not require any additional studies.

The new drug contains the same active ingredient as J&J's new antipsychotic Invega and uses Elan Corp's NanoCrystal technology. Invega is the follow-up to the firm’s blockbuster Risperdal (risperidone) but analysts have also been disappointed by its sales thus far and it is struggling to shake off its ‘me-too’ tag.