The drug, called Cobenfy and developed by US pharmaceutical company Bristol Myers Squibb, targets different receptors (dopamine receptors) from those targeted by the treatments used so far.
"For the first time in several decades, this drug offers a new approach to treating schizophrenia," said Tiffany Farcione of the US Food and Drug Administration (FDA) in a press release.
"This approval offers a new alternative to previously prescribed antipsychotic medications," she added.
Schizophrenia affects about 1 percent of Americans and can cause hallucinations, difficulty controlling thoughts and feelings of persecution. About 5% of those suffering from it die by suicide.
This new drug "could be a game changer, especially for people for whom other treatments don't work," said Lynsey Bilsland, head of mental health at the Wellcome Foundation.
"Its mode of action is completely different to other drugs currently used to treat schizophrenia. It has the potential to change the lives of millions of people," she added.
The drug is taken orally, and its effectiveness has been evaluated in two clinical trials that showed it significantly reduced symptoms in treated people.
Side effects may include nausea, vomiting, indigestion, diarrhea, constipation, urinary retention, and liver problems.
However, according to Matt Jones, professor of neurology at the University of Bristol, these side effects appear to be "reduced" compared to current treatments. "This is very good news for patients," he explained.
"Unfortunately, currently available antipsychotics have significant side effects, including weight gain and impact on movement, which can affect patients' adherence to treatment," agreed Samir Jauhar, a psychiatrist at King's College London.
"This is probably one of the most exciting developments in our field," he concluded, while stressing the need for longer-term clinical trials to confirm these benefits. | BGNES