Allergan, Gedeon Richter plan depression submission
- Allergan plc and Gedeon Richter Plc.'s drug Vraylar (cariprazine) has scored a second success in pivotal studies in acute bipolar I depression.
- In the RGH-MD-54 study, Vraylar was more effective than placebo at both 1.5 mg and 3 mg doses in improving the score on a depression rating scale.
- The next step will be to file a supplemental New Drug Application with the Food and Drug Administration for Vraylar, and this is planned for the second half of 2018.
Vraylar (cariprazine), which was discovered by Gedeon Richter and developed in collaboration with Allergan, has already been approved for acute treatment of manic or mixed episodes in bipolar 1 disorder and for schizophrenia. After getting a pushback in the form of a Refusal to File letter from the Food and Drug Administration in September for the treatment of negative symptoms of schizophrenia, Allergan is having another go, this time targeting acute bipolar I depression.
"These Phase 3 data provide further support for cariprazine as a potential treatment for adults with bipolar depression, and adds to the growing clinical profile of this compound in mental health disorders," said David Nicholson, Chief Research & Development Officer at Allergan.
Bipolar depression can be difficult-to-treat, and there are few approved drugs that treat BPD alone or the full spectrum of the disorder.
"Having another product proven to treat the full range of bipolar disorder would be a welcome addition to the treatment options currently available to the psychiatry community and patients," said Gary Sachs of Harvard Medical School.
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