Dive Brief:
- Allergan plc said April 3 its antipsychotic drug cariprazine met the primary endpoint in a Phase 3 study of acute bipolar I disorder, marking the third positive late-stage trial readout in this indication.
- At the lower dose of 1.5 mg, cariprazine improved patient scores compared to placebo on both the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression Scale-Severity (CGI-S) at six weeks.
- Interestingly, however, the highest 3 mg dose tested did not show a statistically significant benefit over placebo on those metrics, although a numerical trend in favor of the drug was observed. Allergan aims to submit a supplementary New Drug Application (sNDA) for cariprazine — currently marketed as Vraylar for two other indications — sometime in the second half of 2018.
Dive Insight:
Back in August 2016, Vraylar (cariprazine) fell short of its primary endpoint in a major depressive disorder study. Allergan and partner Gedeon Richter plc, however, continued development in other forms of depression — a bet which has yielded three positive study readouts in bipolar I depression, a hard-to-treat subtype of the disorder.
RGH-MD-53, as the recently read out trial is known, is an identical study to RGH-MD-54, which reported data in late 2017. Earlier results from the '54 study supported the drug's efficacy at both 1.5 mg and 3 mg for the primary outcome, as measured by the MADRS. In this third study, though, the higher dose missed statistical significance on both its primary and secondary goals — a result that could give raise some questions at the Food and Drug Administration.
Vraylar is one of several important new drugs for Allergan, earning net revenues of $87.7 million in the fourth quarter of 2017 and $288 million on the year.
Not all of Allergan's efforts to expand the market for Vraylar have panned out, however. Last fall, the Food and Drug Administration issued a refusal to file letter in response to Allergan's sNDA for Vraylar as a treatment of negative symptoms of schizophrenia.
Vraylar currently holds approvals for schizophrenia and for the acute treatment of manic or mixed episodes in bipolar I disorder.