Health
New schizophrenia drug gets FDA approval, taking novel approach to treating brain disorder
A new drug has been approved for the treatment of schizophrenia in adults.
On Thursday, the U.S. Food and Drug Administration (FDA) approved COBENFY (xanomeline and trospium chloride), an oral medication that is manufactured by Bristol Myers Squibb in New Jersey.
This marks the first new class of medications for the brain disorder in several decades, according to a press release.
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COBENFY is expected to be available in the U.S. in late October, the company noted.
A new drug has been approved for the treatment of schizophrenia in adults. (iStock)
“Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” said Chris Boerner, PhD, board chair and chief executive officer at Bristol Myers Squibb, in the press release.
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Schizophrenia is a serious mental illness that affects a person’s thoughts, feelings and behaviors.
It often causes hallucinations, delusions, disordered speech and loss of touch with reality, Mayo Clinic states on its website.
COBENFY (xanomeline and trospium chloride) is an oral medication that is manufactured by Bristol Myers Squibb in New Jersey. (Bristol Myers Squibb)
The disorder can also lead to lack of emotional expression, lack of motivation, cognitive dysfunction and social withdrawal.
Approximately 2.8 million people in the U.S. and 24 million people globally are living with schizophrenia.
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The disorder has traditionally been treated with antipsychotic medications, but around 40% of patients do not respond to treatments and 60% experience “inadequate improvement” in symptoms or “intolerable side effects,” studies have shown.
COBENFY is expected to be available in the U.S. in late October, the company noted. (Bristol Myers Squibb)
COBENFY works differently than the currently available schizophrenia medications.
“Due to its heterogeneous nature, schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of discontinuing and switching therapies,” said Rishi Kakar, MD, chief scientific officer and medical director at Segal Trials and investigator in the drug’s clinical trials, in the release.
“Schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of discontinuing and switching therapies.”
“The approval of COBENFY is a transformative moment in the treatment of schizophrenia because, historically, medicines approved to treat schizophrenia have relied on the same primary pathways in the brain.”
“By leveraging a novel pathway, COBENFY offers a new option to manage this challenging condition.”
“Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community,” said Chris Boerner, PhD, board chair and chief executive officer at Bristol Myers Squibb. (iStock)
Sam Clark, founder and CEO at Terran Biosciences — a biotech company that develops treatments and technologies for neurological and psychiatric diseases in New York City — commented on the new approval in a statement sent to Fox News Digital.
“I am excited that the FDA has just approved [COBENFY] as a treatment for patients with schizophrenia, marking a big leap forward in the psychiatry space,” he said.
“These patients live with a difficult disease, and this drug with a novel mechanism of action will surely make a significant impact,” Clark continued.
“We look forward to seeing the renaissance continue as this approval paves the way for future breakthroughs and novel patient-focused therapeutics.”
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The approval follows three phases of clinical trials in which COBENFY was shown to result in a “statistically significant improvement in illness.”
Schizophrenia is a serious mental illness that affects a person’s thoughts, feelings and behaviors and often causes hallucinations and delusions. (iStock)
In terms of safety, the medication’s most common side effects during clinical trials were nausea, indigestion, vomiting, diarrhea, constipation, hypertension, abdominal pain, accelerated heart rate, dizziness and gastroesophageal reflux disease, the release stated.
Patients with certain existing medical conditions may experience other, more serious risks.
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People should discuss potential complications with a doctor before starting the medication.
Fox News Digital reached out to Bristol Myers Squibb and the Schizophrenia & Psychosis Action Alliance requesting comment.
Health
Katie Couric couldn’t remember the year or the president during frightening brain episode
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Journalist Katie Couric is sharing a scary medical episode that she experienced on June 27.
In a post on Substack titled “The Day I’ll Never Remember,” she detailed a sudden episode that left her unable to recall the current month, year and president.
“I thought it was 2024. And I believed Joe Biden was president,” she wrote.
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The event occurred while Couric was attending the Aspen Ideas Festival in Colorado, during which she participated in two public panels — one on AI and one on journalism — both of which she cannot remember at all.
“I have no idea what we talked about, or of what occurred when the panels ended,” she said.
Journalist Katie Couric is sharing a scary medical episode that she experienced on June 27. (Getty Images)
John Molner — Couric’s husband, who was in attendance at the festival and the two panels — also shared his account.
After the event, someone told Molner that Katie wasn’t feeling well. When he reached her, an EMT and a doctor were tending to her. “I could tell something was off,” he wrote. “It could have been altitude sickness, but Katie was definitely not all there.”
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At the hospital, when Couric struggled to recall the year, the president and her grandchildren’s names, doctors began checking for a stroke.
An MRI revealed no signs of stroke, which was a relief, but “Katie’s ‘fog’ became a lot more apparent,” Molner wrote.
John Molner, Couric’s husband, who was in attendance at the festival and the two panels, also shared his account. (Getty Images)
“She repeatedly asked me the same questions: ‘What was I doing before we got to the hospital?’ ‘Why am I at the hospital?’”
Couric was ultimately diagnosed with transient global amnesia, a sudden, temporary episode of memory loss that prevents a person from forming new memories and may also erase some recent memories, according to Mayo Clinic.
“The cause seems to be as mysterious as the brain itself.”
It is not caused by a stroke, seizure or head injury, and it usually resolves completely within 24 hours.
“[It’s] just a very weird neural episode that’s pretty uncommon and, at least in most cases, is a ‘one and done’ experience,” Molner said.
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Couric said she finally began feeling “like herself” again around 9 p.m. and went to sleep at 2 a.m.
As TGA leaves a “permanent gap in memory” for the duration of the episode and for hours beforehand, Couric said that from around noon on that day until at least 7 p.m. will remain a “big, black hole.”
As TGA leaves a “permanent gap in memory” for the duration of the episode and for hours beforehand, Couric said that from around noon on that day until at least 7 p.m. will remain a “big, black hole.” (Getty Images)
Data shows that approximately three to eight people per 100,000 will have an episode of transient global amnesia, with people 50 years of age and older at higher risk.
The specific cause of TGA is not known, but some experts believe it stems from a “temporary dysfunction in the brain’s hippocampus — the area responsible for creating new memories,” Couric shared.
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“Doctors believe this is driven by brief interruptions in blood or oxygen flow, or microscopic spasm in the blood vessels.”
Episodes could potentially be triggered by intense physical exertion, emotional distress, extreme temperature changes or migraines, experts say.
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Approximately 15% of patients will have a recurrence 10 years later.
“Why did this happen to me? Was the altitude an issue? Was I dehydrated? Tired? Stressed? The literature doesn’t seem to indicate that these are contributing factors, but the cause seems to be as mysterious as the brain itself,” Couric wrote.
Anyone who experiences sudden memory loss, confusion, difficulty speaking, weakness, numbness, vision changes, severe headache or other stroke-like symptoms should seek immediate medical attention or call 911, doctors advise. (iStock)
“All I know is that those hours will be forever lost. Someone described it as my brain failing to hit the ‘record button.’”
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“While this was a freaky occurrence, it could have been much more serious. So ultimately, I’m relieved — even though several hours of a Saturday in June will always be missing for me.”
Anyone who experiences sudden memory loss, confusion, difficulty speaking, weakness, numbness, vision changes, severe headache or other stroke-like symptoms should seek immediate medical attention or call 911, doctors advise.
Health
One walking habit could signal a healthier brain after 80, scientists say
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Older adults identified as “super movers” are about half as likely to develop cognitive impairment than their peers.
That’s according to a recent study led by Stony Brook Medicine in New York, which evaluated the cognitive function of 4,000 adults 80 and over who participated in multiple aging and longevity studies over several years.
Among this group, 6% to 10% were classified as super movers, which means they walk at a much faster pace than others of the same age and gender — at speeds comparable to people three decades younger.
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The super movers were found to have about half the risk of cognitive decline compared to seniors with typical gait speed.
The findings were published in the journal Neurology on June 16.
Older adults identified as “super movers” are about half as likely to develop cognitive impairment than their peers. (iStock)
“The study reinforces that mobility and brain health are closely connected,” lead study author Dr. Joe Verghese, MD, neurologist at Stony Brook Medicine, told Fox News Digital. “This suggests that preserving mobility may be an important marker of healthy brain aging and resilience.”
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The most intriguing finding, according to Verghese, was that super movers maintained cognitive function despite having similar dementia-related brain changes as their peers.
In postmortem brain analysis, there was no difference in dementia-related pathologies between the super movers and the slower walkers, the study stated.
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“This suggests they may possess resilience mechanisms that help preserve brain function even in the presence of age-related changes,” he said. “Understanding these resilience factors could lead to new strategies for promoting healthy brain aging.”
As the study was observational, there were some limitations, and it does not prove that walking faster prevents dementia, the researchers noted.
Super movers were found to have about half the risk of cognitive decline compared to seniors with typical gait speed. (iStock)
“Other factors, such as cardiovascular health, physical fitness or genetics, may also contribute to both faster walking and better cognitive outcomes,” Verghese said.
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This study adds to growing evidence that what’s good for the heart and muscles also benefits the brain, he noted, adding that “staying physically active remains one of the most effective, evidence-based ways to support healthy aging.”
“Walking speed is best viewed as a marker of overall health, not a treatment.”
“The broader message is that physical activity is important at any age,” Verghese said. “Walking is an easy step-up point because you don’t need any special equipment. You can do it inside or outdoors, and you can do it on a regular basis. You can walk with a dog, you can walk with a friend.”
Any activity is beneficial if it’s done regularly and with the right intensity, he added.
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Rather than just trying to walk faster, the neurologist recommends that seniors focus on maintaining mobility through regular physical activity, strength training, balance exercises and good cardiovascular health.
“Walking speed is best viewed as a marker of overall health, not a treatment,” Verghese noted.
Major public health guidelines from the CDC and U.S. Physical Activity Guidelines recommend at least 150 minutes of moderate-intensity aerobic activity each week, such as brisk walking.
Major public health guidelines from the CDC and U.S. Physical Activity Guidelines recommend at least 150 minutes of moderate-intensity aerobic activity each week, such as brisk walking. (iStock)
This can be achieved by walking 30 minutes a day, five days a week, or about 20 to 25 minutes most days. Another option is to engage in shorter sessions that add up over the day.
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“You have to do it within your health limitations and medical conditions,” Verghese advised. “So if there are any medical concerns, I would get your physician to clear you before starting exercise.” The good thing about walking, he added, is that you can start at a slow pace and then gradually build up to a brisker pace.
“And then adding on strength and balance training, whatever age you are, I think is also important.”
Health
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