Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Gedeon Richter Plc., today announced positive topline results for RGH-MD-53, a Phase 3 study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). The companies announced in December 2017 positive topline results for the second pivotal trial (RGH-MD-54) of cariprazine in the treatment of bipolar I depression. In the previous trial both cariprazine 1.5mg and 3mg were statistically greater than placebo.
The efficacy of cariprazine in the treatment of bipolar I depression has been demonstrated in three positive pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56. Allergan plans to include data from all three pivotal trials in the Company's Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2018. Cariprazine is currently approved in the U.S. under the brand name VRAYLAR for the treatment of schizophrenia in adults, and acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
"We are very pleased with the results of our third pivotal study, which reinforce the wealth of data supporting cariprazine as a potential treatment in adults with bipolar depression" said David Nicholson, Chief Research & Development Officer at Allergan. "Bipolar depression is often difficult to treat and can be extremely debilitating for patients.
One potential concern related to the RGH-MD-53 study is that while the 1.5 mg dose group's results were significantly better than placebo, the 3 mg dose results were not significantly better than placebo. However they were numerically superior.
In another previous study, found here, cariprazine results were significantly better than placebo in the participants receiving 1.5 mg/day and 3 mg/day. The group receiving .75 mg/day had results similar to placebo.
If the sNDA is approved it will be a welcome addition to physicians treating bi-polar I depression. The disease is difficult to treat and there are few approved treatment options.
A 2014 study found that the overall lifetime prevalence of Bi-polar depression in the US is 4.4%. The 12 month prevalence of BP I was 0.6%.