FDA approves drug to treat agitation from schizophrenia
First from Conn.-based BioXcel Therapeutics to go to market
BioXcel Therapeutics, a New Haven-based biotechnology company, has received federal Food and Drug Administration approval to bring its first drug to market, company officials said.
The drug, which has the brand name Igalmi, will be launched in the United States by the end of June. It is for the treatment of acute agitation associated with schizophrenia or bipolar I or II disorder.
Igalmi comes in the form of a thin, film-like strip that dissolves quickly when placed anywhere in the lining of the mouth.
Vimal Mehta, BioXcel’s chief executive officer, said Igalmi “is the first new acute treatment for schizophrenia or bipolar disorderassociated agitation in nearly a decade.”
“We believe it has significant market-changing potential, and we are excited to execute on our commercial launch plans,” he said.
In the pharmaceutical industry, drugs that yield annual sales of more that $1 billion are considered blockbusters. One example of a blockbuster drug is Eliquis, which was developed by Bristol-Myers Squibb and Pfizer, to lower the risk of strokes and blood clots in people with an irregular heartbeat known as atrial fibrillation.
During the first nine months of 2021, Eliquis produced $8.09 billion in sales. Mehta said Igalmi has the potential to achieve blockbuster status over time.
“It certainly has the potential to be huge,” he said.
In the year leading up to Wednesday’s announcement, BioXcel has doubled the size of its workforce. The company now employs 100 people.
An estimated 7.3 million people in the U.S. are diagnosed with schizophrenia or bipolar disorders, according to company officials.
Dr. John Krystal, chairman of psychiatry department at Yale University’s School of Medicine, said the FDA approval “represents a milestone moment.”
“In these episodes of extreme agitation, these individuals can hurt themselves or the people who are trying to help them,” said Krystal, who was a strategic clinical adviser to BioXcel. “This is designed to help them to regain self-control.”
Acute agitation associated with schizophrenia or bipolar I or II disorder can quickly escalate to the point that a patient needs to be placed in physical restraints or in isolation, he said. That can discourage patients from seeking medical help or taking drugs that are prescribed to them, according to Krystal.
Medications prescribed for this type of acute agitation can result in “side effects that are quite unpleasant” if high doses of the drugs have to be given, he said.
“These are some of the worst experiences people can have,” Krystal said.
One side effect is dystonia, a movement disorder in which muscles contract involuntarily, causing repetitive or twisting movements, he said. The side effect of another treatment mimics the shaking associated with Parkinson’s disease.
“It’s all very scary to patients,” Krystal said. “I’ve had patients who are so frightened by dystonia that they no longer want to be treated.”
Paul Pescatello, senior counsel and executive director of the Connecticut Business & Industry Association’s Growth Council, said the use of artificial intelligence “is very cutting edge,” but said its usage is still in a relatively early stage. Using AI allows companies to bring drugs to market more quickly and more cost effectively, according to Pescatello.
“The fact that a Connecticut company is at the forefront of this is very impressive,” he said.
Mehta said AI enabled BioExcel to move Igalmi through the drug research and development process to FDA approval in just five years. That is nearly half the amount of time it takes most drugs to make it through the approval process.