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Clinical Trials

Date: 2017-12-18

Type of information: Results

phase: 3

Announcement: results

Company: Gedeon Richter (Hungary) Allergan (Ireland)

Product: cariprazine

Action mechanism:

  • dopamine D3 receptor partial agonist. Cariprazine has been discovered by researchers at Gedeon Richter. This orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2700 patients. In addition, cariprazine is being investigated for the treatment of bipolar depression and adjunctive MDD in adults. Cariprazine is licensed to Actavis, now Allergan, in the U.S. and Canada.
  • Cariprazine was approved by the FDA in September 2015 and is marketed as Vraylar™ in the US for the treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adults.

Disease: bipolar depression

Therapeutic area: CNS diseases - Mental diseases

Country:

Trial details:

  • RGH-MD-54 is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, fixed-dose clinical trial in patients with bipolar I depression. A total of 488 patients were randomized in this study aiming to evaluate the efficacy, safety, and tolerability of cariprazine 1.5 mg/day and 3.0 mg/day compared to placebo in patients with bipolar I depression. Subjects underwent a no-drug screening period of approximately 7-14 days, followed by 6 weeks of double-blind treatment and a 1-week, no investigational product safety follow-up period.

Latest news:

  • • On December 18, 2017,  Allergan and Gedeon Richter announced topline results for a phase 3 study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). This is the second positive pivotal trial of cariprazine for this investigational use.
  • In this study, the primary efficacy objective was met for both cariprazine 1.5mg and 3mg dose groups (p<0.05). Both showed a significantly greater improvement than placebo for the change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
  • In this study, cariprazine was generally well tolerated. Sedation, somnolence, dizziness, akathisia and nausea were the most commonly reported adverse events (reported with a frequency of 5% or greater and at least twice that of placebo). In this study, 5.0% of cariprazine treated patients discontinued due to adverse events versus 2.5% of placebo treated patients.
  • The company plans to submit a supplemental New Drug Application (sNDA) to the FDA in the 2nd half of 2018.
 

Is general: Yes