Antipsychotics News: Cariprazine, Risperidone and New Drug Applications

Author: Flavio Guzman, MD
Editor
Psychopharmacology Institute
Dr. Guzman has no conflicts of interest to disclose.

Last updated: October 19, 2017 at 17:47 pm

Cariprazine for Negative Symptoms of Schizophrenia: The FDA Refuses to Review Supplemental New Drug Application (sNDA)

Negative symptoms of schizophrenia have proven particularly difficult to treat

The FDA has refused Allergan’s request to review a Supplemental New Drug Application (sNDA) to expand the approved uses to include negative symptoms of schizophrenia [1]. The FDA stated that its preliminary appraisal found the sNDA not sufficiently complete to permit a substantive review.

Cariprazine was found to be efficacious in reducing negative symptoms compared with risperidone in a recent clinical trial published in 2017 [2].

About Cariprazine

  • Cariprazine is a D2 and 5-HT1A partial agonist (like aripiprazole and brexpiprazole). It also has 5-HT2A antagonist properties.
  • Cariprazine is FDA-approved for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder.

Risperidone: A Subcutaneous Long-Acting Injectable Formulation?

  • Name of the investigational compound: RBP-7000
  • Drug: risperidone
  • Manufacturer: Indivior
  • Route of administration: subcutaneous
  • Technology: Atrigel, biodegradable polymer

Indivior Inc. has submitted a New Drug Application (NDA) to the FDA for its investigational compound RBP-7000, a once-monthly injectable formulation of risperidone [3]

The NDA submission includes the results from both a randomized, placebo-controlled phase 3 study of inpatients with an acute exacerbation of schizophrenia and an open-label, long-term safety study [4].

About Risperidone Long-Acting Injection

  • Risperidone was the first second-generation antipsychotic available in a long-acting injectable formulation
  • Risperidone microspheres (Risperdal Consta, Janssen)  is the only LAI currently available
    • Requires a period of overlap of 3 weeks with oral risperidone
    • 2-week dosing interval

References

  1. Allergan Receives Refusal to File Letter from FDA for Vraylar® (cariprazine) Supplemental New Drug Application (sNDA) for the Treatment of Negative Symptoms in Schizophrenia. Source: Allergan Investor News. Accessed October 17, 2017
  2. Németh, G., Laszlovszky, I., Czobor, P., Szalai, E., Szatmári, B., Harsányi, J., … & Marder, S. (2017). Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial. The Lancet389(10074), 1103-1113.
  3. Indivior Submits New Drug Application to U.S. FDA for RBP-7000 Risperidone Monthly Depot for Treatment of Schizophrenia. Source: Indivior Investor News. Accessed October 17, 2017
  4. Nasser, A. F., Henderson, D. C., Fava, M., Fudala, P. J., Twumasi-Ankrah, P., Kouassi, A., & Heidbreder, C. (2016). Efficacy, safety, and tolerability of RBP-7000 once-monthly risperidone for the treatment of acute schizophrenia: an 8-week, randomized, double-blind, placebo-controlled, multicenter Phase 3 study. Journal of clinical psychopharmacology36(2), 130-140.

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