Johnson & Johnson’s (JNJ) Janssen Research & Development is seeking FDA approval for a three-month formulation of its long-acting atypical antipsychotic, paliperidone palmitate, for the treatment of adults suffering from schizophrenia.

A once-monthly formulation of paliperidone palmitate is currently available under the trade name Invega Sustenna for the treatment of schizophrenia.

As per the company, if the three-month formulation is approved, it will be the first and only long-acting atypical antipsychotic with a four times a year dosing schedule.

Johnson & Johnson’s NDA submission was based on results from a phase III international, randomized, multicenter, double-blind, relapse prevention study on the three-month formulation. The study was halted early on recommendation of an Independent Data Monitoring Committee (:IDMC) based on certain positive efficacy results (read more: Good News for Johnson & Johnson).

The NDA submission for the three-month formulation comes close on the heels of the approval of Invega Sustenna as monotherapy or adjunctive therapy for the treatment of schizoaffective disorder. This is the first and only FDA-approved once-monthly monotherapy for the treatment of schizoaffective disorder.

Our Take

The approval of the three-month formulation will strengthen Johnson & Johnson’s position in the schizophrenia market. The company also has another established schizophrenia treatment, Risperdal Consta, in its portfolio. Risperdal Consta recorded sales of $896 million for the nine months ending Sep 2014.

Other major drugs in the schizophrenia market include Bristol-Myers Squibb Company’s (BMY) Abilify (nine months 2014 sales of $1.5 billion) among others.

Johnson & Johnson is a Zacks Rank #3 (Hold) stock. Some better-ranked companies in the health care space are Allergan (AGN) and AbbVie Inc. (ABBV). While Allergan holds a Zacks Rank #1 (Strong Buy), AbbVie carries a Zacks Rank #2 (Buy).

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