The antipsyhoctic could receive a new indication in 2019, and though the field of bipolar disorder care is far from perfect, it should improve with this addition.
Michael Thase, MD
Barring the unexpected, cariprazine (Vraylar) should receive yet another indication for psychiatric use in 2019.
The atypical antipsychotic therapy from Allergan—previously approved for the treatment of adults with schizophrenia, and manic or mixed episodes associated with bipolar 1 disorder—will soon await US Food and Drug Administration (FDA) decision on its supplemental New Drug Application as a treatment for depressive episodes in bipolar adults.
The field it would likely be joining soon is relatively small, occupied just a few more antipsychotic therapies on the market, Michael Thase, MD, told MD Magazine®.
Thase, a professor of psychiatry at the Perelman School of Medicine, University of Pennsylvania, explained that cariprazine has shown clinical benefits that improve on current antipsychotics—which, as a class, are already superior to previous antidepressant options for patients with bipolar 1 disorder.
That said, the field of care is far from reaching its fullest potential. What cariprazine would deliver, Thase explained, is just possibly the next best drug.
MD Mag: What are your thoughts on cariprazine and the current state of bipolar care?
Thase: The story here is that you’ve got quetiapine, fluoxetine, and lurasidone all approved in bipolar depression. But they each have some side effect issues. But cariprazine would be certainly the least sedating—and possibly with the least weight gain, among the 4 of those drugs. So there probably is room for a fourth. And cariprazine has had a few more indications for a couple of years now, so this would basically give them bookends in this area of therapeutics.
What stands out is its benefits for both symptoms and common side effects. Can you speak more to those qualities?
It’s not sedating. Some people think it might be activating, which means beyond not being sedating, it might help a person with low energy feel energetic, a person with no motivation feel more drive. Because it is a dopamine partial agonist.
This could be critical for treating patients with what appears to be a very dynamic disease.
The thing people like with the newer generation of psychotics for bipolar depression is that not only do they work, but they don’t have the risk of causing a switch into mania, hypomania, or cause rapid cycling. From that standpoint, they have the advantage over many anti-depressants—many of which have not even been proved to work in bipolar depression. There’s a disadvantage of maybe not working, plus an added risk.
For most people with bipolar disorder, they spend more days depressed than high or hypomanic, so having an anti-depressant that’s well tolerated but doesn’t cause sedation or weight gain is a desirable.
Are we getting any more closer to what you imagine to be the best-case scenario for bipolar and depression therapies?
No. There’s a lot of work to be done. I think what this does is simply put another arrow in the quiver. There will be some patients for whom cariprazine will be a better choice than other existing agents, and so that makes us better to help more people. But ultimately, you’d like to be able to ascertain which of the arrows would be the most likely to hit the mark. And we do not have that at hand yet.
How much longer do we have to go to reach that? What sort of clinical advances do we need to make?
I can’t imagine, because the end is not in sight. We’re a long way from having that kind of information.
What sort of improvements have we seen in care provider collaboration or teamwork for psychiatric care?
I think we’re starting to see people using antidepressants less. We’ve made advances there, and in the notion that we can use focused psychotherapy in lieu of antidepressants is an added benefit, because of course psychotherapies don’t have same magnitude of side effects. There are some psychotherapy side effects—it’s conceivable to suggest that coming out depression care might put you at some heightened risk for becoming manic or hypomanic. So I’m not saying the therapies are risk-free, and they’re done sometimes for months and years without a demonstrable benefit in the real world, but having focused psychotherapy seems to work at least as well as conventional pharmacotherapies.
Beyond lithium, you have a range of medicines that originally came out of the anti-convulsive part of the pharmacopeia. And now you have 3—soon to be 4—newer generation antipsychotics. So we are in a better place.