Allergan and its developmental partner Gedeon Richter Ltd. are eying an add-on approval from the U.S. Food and Drug Administration for a depression treatment based on new Phase III data released Tuesday.
Allergan and its developmental partner Gedeon Richter Ltd. are eying an add-on approval from the U.S. Food and Drug Administration for a depression treatment based on new Phase III data released Tuesday.
The two companies released topline results for RGH-MD-53, a Phase III study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder. The companies said cariprazine met the endpoints of the late-stage study and plan to send it on to the FDA in a supplemental New Drug Application.
If the FDA gives the add-on nod it would be the second one in about a year’s time. In November 2017 the FDA approved an additional indication for cariprazine, which is sold as Vraylar. The FDA approved the drug or the maintenance treatment of adults with schizophrenia. It was initially approved for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder in adults.
Bipolar disorder, which is also known as manic-depressive illness, causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks, according to the National Institute of Mental Health. Bipolar I disorder is defined by manic episodes that last at least seven days and typically requires immediate hospital care.
Gary Sachs, an associate clinical professor of psychiatry at Harvard Medical School, said treating bipolar depression is difficult due to the limited therapies available for bipolar I disorder. He touted the Allergan/ Gedeon Richter data because it “demonstrates cariprazine’s potential in treating the full spectrum of the disorder.”
Data from the latest study showed that patients treated with a 1.5 mg dose of cariprazine saw a significantly greater improvement in the change from baseline to week 6 measured against placebo on two depression scales. Allergan said a 3 mg dose showed a numerical improvement over placebo but did not reach statistical significance.
“Today’s positive results provide further support for the therapeutic value of cariprazine, one of our flagship products. We are encouraged by the findings, which mark a major step forward in making this promising treatment option available for patients suffering from bipolar depression,” István Greiner, research director at Gedeon Richter Plc. said in a statement.
While cariprazine has successfully wound its way through the clinic on multiple occasions the drug has had some setbacks. In September 2017 the FDA issued a Refusal to File letter regarding a sNDA for treatment of negative symptoms associated with schizophrenia in adult patients.
Now though, the drug could be on its way to receive another supplemental approval. Allergan said the efficacy of cariprazine for the treatment of bipolar I depression has been demonstrated in three positive pivotal trials, including the most recent one, as well as RGH-MD-54 and RGH-MD-56. In December 2017 data from the RGH-MD-54 trial was released that showed both cariprazine 1.5mg and 3mg were statistically greater than placebo. The Ireland-based company and its Hungarian development partner intend to include the data from all three trials in its supplemental New Drug Application.
“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” David Nicholson, Allergan’s chief research & development officer said in a statement. “Bipolar depression is often difficult to treat and can be extremely debilitating for patients. At Allergan, we are committed to developing treatments that address unmet needs facing people living with mental illness and are looking forward to submitting a sNDA for cariprazine for patients suffering with bipolar I depression.”
