Janssen-Cilag Submits MAA For Paliperidone Palmitate

Elan Drug Technologies, a business unit of Elan, has reported that Janssen-Cilag has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for Paliperidone Palmitate, aimed at the treatment of schizophrenia.

Paliperidone Palmitate, an investigational, once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia and the prevention of recurrence of the symptoms of schizophrenia. Paliperidone palmitate is an injectable ester of the active ingredient in invega and utilises Elan’s NanoCrystal technology.

The NanoCrystal technology, a technology enabling the formulation of poorly water soluble compounds for all routes of administration, facilitated the development of a stable, low viscosity, high drug loaded formulation of Paliperidone Palmitate.

The company said that the application of the NanoCrystal technology has allowed for a ready-to-use one month duration intramuscular injectable formulation to be developed. This product was approved by the FDA earlier this year.