Vraylar has been on the market for four years. FDA officials recently gave their approval for the drug to be used to treat bipolar depression.
The Food and Drug Administration (FDA) has approved a medication that’s been on the market for more than four years to treat another condition: bipolar depression.
Vraylar was initially approved in 2015 for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.
However, since then, its makers — Allergan and Gedeon Richter — have been testing the drug in hopes of getting FDA approval for a variety of other mental health conditions.
The most recent approval is specific to adults who experience depressive episodes associated with bipolar I disorder. It’s already approved to treat manic or mixed episodes in people with the same condition.
The National Institute of Mental Health estimates that about 4 percent of all adults in the United States experience bipolar disorder at some point in their lives.
So, the new approvals for Vraylar — namely treating both the trademark depressive and manic episodes — make the once-daily pill more likely to be prescribed and used by more people.
And because this approval is for a drug that’s already in psychiatrists’ medicine cabinets, the prescribing has already begun.
“It brings a lot of hope to patients,” Dr. Gustavo Alva, a California-based psychiatrist and paid promotional speaker for Vraylar and other medications, told Healthline. “It’s one of the few [medications] to treat the full spectrum of bipolar disorder.”
Vraylar is a once-daily atypical antipsychotic, or a second-generation antipsychotic.
“While the term ‘antipsychotic’ typically scares people about these treatments, the term is really just a class name and these drugs are used, yes, primarily to treat psychosis, but also affective disorders, anxiety disorders, and attention-deficit/hyperactivity disorder, although in most cases, they are used alongside something else,” Natasha Tracy, the author of “Lost Marbles: Insights Into My Life with Depression and Bipolar,” told Healthline.
The FDA has approved Vraylar in doses of 1.5 and 3 milligrams in adults with a diagnosis of bipolar I disorder who experience depressive, manic, or mixed episodes.
It’s also approved up to 6 milligrams a day for adults with schizophrenia. Its makers are seeking FDA approval for adults with depression not linked to bipolar disorder.
“It may be the case that schizophrenia and bipolar disorder actually exist along a spectrum, with something like schizoaffective disorder in the middle, and so treatment with similar medications does make sense,” Tracy said.
Vraylar’s main active ingredient is cariprazine, which Gedeon Richter’s research director István Greiner, PhD, describes in a press release as the pharmaceutical company’s “flagship product.”
Vraylar joins other branded and on-patent atypical antipsychotics — including Seroquel, Zyprexa, and Latuda — to treat various states of bipolar disorder.
As with many mental health conditions, there’s no one-size-fits-all magic pill that can help every person control their symptoms. Often, mental health professionals try several medications before finding the right one.
But the makers of Vraylar — as well as experts compensated by them — see it as a welcome addition to the market.
Dr. Stephen Stahl, a professor of psychiatry at the University of California San Diego and another paid promotional speaker for Vraylar, was the lead author on the analysis of the three randomized, double-blind, placebo-controlled trials submitted to the FDA for approval.
“Treating depression, mania, and mixed episodes with a single medication is important for people living with and healthcare providers treating this complex illness,” he said in the announcement for Vraylar’s latest FDA approval. “This approval can streamline a treatment decision while helping to stabilize the disorder.”
But, like many other psychiatric drugs, its makers acknowledged to the FDA that they don’t exactly know its mechanism of action.
In other words, their tests suggest it’s safe in the general population and can achieve desired effects in people with certain diagnosed mental conditions, but they don’t exactly fully understand how it gets those results.
The companies say Vraylar “could” work as a partial agonist against dopamine and serotonin, two chemicals in the brain associated with mood and emotional regulation, much like other drugs.
While not knowing a drug’s mechanism is common, Alva says “the proof is in the pudding” as six studies now show favorable outcomes for most patients taking it. And the drug has already been available to psychiatrists for treating schizophrenia, so many are already familiar with it.
“We’ve had a good four-year run with this medicine,” Alva said. “You see benefits as early as two weeks.”
One potential cause for concern is Vraylar’s higher incidence of extrapyramidal symptoms, or involuntary muscle movements, including Parkinsonism and akathisia, or uncontrollable urges to move.
Tracy says atypical antipsychotics are known to have less extrapyramidal symptoms, but studies show these symptoms show up in up to 45 percent of people with bipolar diagnoses who took Vraylar.
“This is a very high number for an atypical antipsychotic,” she said. “It’s worth noting that a small number of movement disorders can be permanent even once the drug is stopped.”
Other more common side effects include headache, nausea, and constipation.
Another positive to Vraylar is that studies appear to show lower rates of metabolic complications, which affect blood sugar and cholesterol levels, important implications for people who need to closely monitor those side effects.
Also, compared with other atypical antipsychotics on the market, Vraylar’s results show fewer people gained weight while taking it.
“If this drug does indeed show weight gain in such a small number, it fills a niche for people who need bipolar depression treatment but can’t withstand the weight gain of some other drugs,” Tracy said.