# Food and Drug Administration FDA

[my-autism-adhd-blog]

Why is everything getting recalled lately? My favorite drink isn’t even safe!

According to the article I found:

Snapchill has initiated a voluntary recall of hundreds of its products after they were found to potentially be harboring grounds for the toxin botulinum, which can cause botulism, a sometimes fatal form of food poisoning.

According to the recall notice posted on the website of the Food and Drug Administration (FDA), the manufacturing process used for the products led to low acid levels in the canned foods. Low acid conditions can lead to the growth and production of botulinum.

I’ll leave the full article below in case anyone wants to read it:

Link to Article

[battleangel]

⛔️FDA BANS HAIR RELAXERS⛔️

[gumjrop]

The FDA, between now and May 8, is accepting public comments for their upcoming vaccine committee meeting. Let them know that all of us need access to COVID vaccines at least twice a year.

Make your voice heard and ask the FDA Vaccines and Related Biological Products Advisory Committee Meeting to:

Ensure vaccine manufacturers anticipate the upcoming dominant strain of SARS-CoV-2.

Recommend updated COVID vaccines for all ages AND

Strengthen our vaccine drive by recommending more frequent boosting (at least every six months) and more frequent updates to the vaccines, adjusted for the latest variants.

Submit a public comment. Feel free to use our sample language below.

You can also register to give Oral Public Comment at the upcoming May 16 online FDA Vaccines and Related Biological Products Advisory Committee Meeting at: CBERVRBPAC@fda.hhs.gov on May 1, 2024. THAT’S TONIGHT!

Submitted written comments for the meeting must be received by the FDA via the Federal Register no later than May 8, 2024 at 11:59 Eastern Daylight Time. 

It’s important to submit a personalized comment, which could include the importance of anticipating the next dominant viral strain, the lack of vaccine access that has impacted or would impact you, or how out-of-pocket costs are a barrier in your family or community. Feel free to take inspiration from or borrow the language in our sample public comment below.

Docket No. FDA–2024–N–0970 Scientific evidence indicates updated vaccines are needed to address the ongoing changes in COVID variants, and they should ideally be allowed, available, and fully covered by public funds and/or insurance, for people of all ages at least every six months. The vaccine schedule should address waning efficacy in the months following vaccination [1-3] as well as emergence of new SARS-CoV-2 strains. The FDA’s decision will affect the current and future vaccine approach including what healthcare providers recommend, what health insurance covers, and level of public engagement. It is of utmost importance that the FDA anticipates the newest viral variants and provides recommendations that anticipates the next dominant strain in the next six months. This requires that the FDA ensure that manufacturers anticipate the newest variants. Restricting vaccinations to only annual updates misses an opportunity, given that there is the potential to update the vaccines to better match perpetually emerging variants. Updates to all vaccine types are needed, and mRNA vaccines are particularly suited to frequent updates. The recommendation for only annual vaccination also creates barriers for vulnerable people and discourages high risk people from getting needed vaccine boosters. The FDA must ensure support equitable and affordable access to updated vaccines and prevent limited access because of financial constraints or demographics by advocating for programs such as the CDC’s bridge program that ensures no cost access. [4] References:

Link-Gelles R. COVID-19 vaccine effectiveness updates. Presented at: FDA VRBPAC Meeting; June 15, 2023. Accessed February 9, 2024. https://www.fda.gov/media/169536/download

Wu N, Joyal-Desmarais K, Vieira AM, et al. COVID-19 boosters versus primary series: update to a living review. The Lancet Respiratory Medicine. 2023;11(10):e87-e88. doi:10.1016/S2213-2600(23)00265-5

Menegale F, Manica M, Zardini A, et al. Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023;6(5):e2310650. doi:10.1001/jamanetworkopen.2023.10650

https://www.cdc.gov/vaccines/programs/bridge/index.html 

Full instructions for written and oral comment and meeting information can be found at: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-may-16-2024-meeting-announcement

FDA Vaccines and Related Biological Products Advisory Committee Meeting on the Federal Register: https://www.federalregister.gov/documents/2024/03/04/2024-04523/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a

[reasonsforhope]

“A new U.S. law has eliminated the requirement that drugs in development must undergo testing in animals before being given to participants in human trials.

Animal rights advocates have long pushed for such a move, and some in the pharmaceutical industry have argued that animal testing can be ineffective and expensive...

Signed by President Biden in December as part of a larger spending package, the law doesn't ban the testing of new drugs on animals outright.

Instead it simply lifts the requirement that pharmaceutical companies use animals to test new drugs before human trials. Companies can still test drugs on animals if they choose to.

There are a slew of other methods that drugmakers employ to assess new medications and treatments, such as computer modeling and "organs on a chip," thumb-sized microchips that can mimic how organs' function are affected by pharmaceuticals.

But Aliasger Salem, a professor at the University of Iowa's College of Pharmacy, told NPR that companies opting to use these alternative testing methods as a replacement for animal testing must be aware of the methods' limits to ensure their drugs are safe.

"The companies need to be aware of the limitations of those technologies and their ability to identify or not identify potential toxicities," Salem said.

"You don't want to shift to systems that might not capture all of the types of toxicities that have been seen in the past without ensuring that the methods that you have will capture that."

An FDA spokesperson told NPR that it will "implement all applicable provisions in the omnibus and continue to work with stakeholders to encourage the development of alternative testing methods."

This year's federal budget also includes $5 million for a new FDA program aimed at reducing animal testing by helping to develop and encourage industry to adopt new product testing methods, the spokesperson said.”

-via NPR, 1/12/23

[xtruss]

We're Having A COVID Summer Surge. Should You Get The Updated Vaccines Now?

The FDA Just Approved an Updated Vaccines, and Officials Say Paxlovid is Still Effective in Preventing Severe Cases.

— By Sanjay Mishra | August 22, 2024

A Colorized Ccanning Electron Micrograph of a Cell (Blue) Infected with the Omicron Strain of the SARS-CoV-2 virus (Yellow). Micrograph By National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes Of Health/Science Photo Library

The summer of 2024—the fifth since the COVID-19 pandemic began—is projected to be the biggest summer wave of COVID infections to date.

Since early May, COVID infections have steadily increased in the United States, Europe, Singapore, New Zealand, and Australia. The U.S. Centers for Disease Control and Prevention estimates that COVID-19 infections are currently increasing in 25 states based on data from emergency department visits. However, hospitalizations and deaths from COVID remain at their lowest levels.

Now, the U.S. Food and Drug Administration has approved updated vaccines to protect against current variants of the virus.

This recent surge has been driven mainly by a new group of closely related Covid subvariants, known collectively as "FLiRT."

As the summer winds down, students across the U.S. will return to school. Traditionally, this also coincides with the season of respiratory viruses, such as flu, RSV, and increasingly COVID.

"Not sure what will happen this fall and winter," says Kei Sato, a virologist at the University of Tokyo. While the FLiRT variants are likely to keep evolving after summer, entirely new subvariants cannot be ruled out. "An Omicron-like event” seems to have occurred every year in the fall since 2021, says Sato.

Here's what you need to know about the new variants and the new vaccines.

What Are FLiRT Variants?

The "FLiRT" variant family includes the majority of currently circulating variants, identified with the letters KP, JN, and the variant LB.1.

The unofficial name "FLiRT" is an acronym for a set of mutations on the spike protein of SARS-CoV-2, the virus that causes COVID-19. The virus uses spike protein to bind with ACE2 receptors in our nose and lung cells to cause infection.

All proteins are made up of amino acids that string together like beads. Mutations can change one amino acid to another, thereby altering the behavior of the protein and making the virus more or less infectious, or able to dodge immunity.

The FLiRT subvariant family members are descended from the JN.1 variant that was dominant in the U.S. in early 2024. JN.1 itself was highly unusual because it acquired 41 mutations that differentiated it from Omicron XBB.1.5, which is the variant upon which the current bivalent COVID booster is based.

Should You Get The New Vaccines?

The two updated mRNA vaccines, manufactured by Pfizer-BioNTech and Moderna, target a FLiRT variant called KP.2. Anyone over the age of 12 can get the new shots, as long as they haven't received a booster in the last two months.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement.

Another vaccine targeting the variant JN.1 and manufactured by Novovax is also under review and could be approved soon.

Previous research also showed that older vaccines based on XBB.1.5, an earlier subvariant of Omicron, were still effective in preventing severe COVID-19. While this vaccine produces antibodies that still target the FLiRT variants, the efficiency is notably reduced. A recent infection from the JN.1 variant also seems to provide strong protection against all the FLiRT variants.

That said, the CDC recommends that everyone six months and older get a COVID vaccine. Those at high risk for serious COVID-19 should get vaccinated with the most recent versions available.

How Alarming Are FLiRT Variants?

Coronaviruses, such as SARS-CoV-2, frequently mutate to avoid recognition by antibodies. The two FLiRT mutations remove the sites on the virus where antibodies bind the SARS-CoV-2 virus.

Additional mutations on the FLiRT variants can either help the virus bind more efficiently to ACE2 receptors making it more infectious, help it evade previous immunity, or both, says Adrian Esterman, an epidemiologist at the University of South Australia, Allied Health & Human Performance in Adelaide, Australia

Early studies show that all existing FLiRT subvariants are very good at dodging previous immunity acquired through multiple COVID vaccinations—including the most recent COVID bivalent booster—or a breakthrough infection from a previous strain of Omicron.

But the good news is that by escaping the antibodies, the FLiRT variants have also seem to lost some ability to infect their target because the virus needed the original antibody-binding sites to bind the ACE2 receptor and enter cells.

"These variants are not yet particularly concerning, even with the new mutations that affect certain aspects of the virus's biology," says Shan-Lu Liu, a virologist at the Ohio State University.

It is common for viruses to acquire mutations that help them dodge immunity, which can affect their ability to infect cells, says Liu. "The viruses can quickly evolve new mutations to restore their infectivity."

But in the meantime, Sato thinks that waning immunity from previous vaccinations and infections, coupled with the FLiRT variant's ability to dodge remaining immunity, are probably the main reason for the recent surge in infections.

Liu also agrees that the currently rising numbers of COVID infections are mostly due to low booster uptake and increased summer travel.

Are COVID Medicines Still Effective?

Emergency department visits, hospitalizations, and deaths have all spiked during this summer but are still much lower compared to earlier waves of the pandemic.

There is no indication that these new FLiRT variants are more dangerous than other Omicron strains.

A study shows that Paxlovid is still effective against FLiRT variants. Other antiviral drugs such as molnupiravir and remdesivir are also expected to work since their mechanism of action is not affected by mutations in the spike protein.

[cripp-tid]

living in the USA really just is reading a news headline like "BREAKING: FDA outlaws cancer-causing food coloring" and you click it and its "beta-dextraflubenrabinol #5 (shortened to beta DFR5), is commonly used in the manufacturing of paintballs. it has been around since 1943. today, it is present in 95% of sodas." and u just kinda go "wtf wasn't that already illegal?" and u look MORE into it on google and find some shit like "the FDA allows up to 12% toxicity in all products meant for consumption" and u just kinda stare into the camera like the office

[whoneedssexed]

This abortion pill "safety" lawsuit should TERRIFY you.

“For reference, pregnancy has a mortality rate of about 8.8 in 100,000, which is 15x higher. Penicillin has a mortality rate of 2 in 100,000, which is 4x higher. And interestingly, Viagra has a mortality rate  of 4 in 100,000, which is 8x higher.”

[an-onyx-void]

Supreme Court rejects challenge to FDA's approval of mifepristone https://www.npr.org/2024/06/05/nx-s1-4994407/supreme-court-mifepristone

[faggotfungus]

My friend sent me a tiktok that was telling people that all eyedrops have been contaminated with human shit and plastics so they're being recalled.

So, like a sane person, I Googled, "Eyedrop recall." First thing I found was this statement by the FDA. There are only 2 eyedrops being recalled, and the bacterium/fungi they're contaminated with are all sourced from the environment (dirt, water, vegitation).

Please don't believe what people say just because they say it enthusiastically.

[religion-is-a-mental-illness]

By: Bernard Lane

Published: Sep 6, 2023

America’s drug regulator, the FDA, has been asked to take urgent action on the unapproved use of hormone suppression drugs to block the natural but unwanted puberty of transgender-identifying children.

“Although this use has not been approved by the [Food and Drug Administration], the FDA must not turn its back on the potential harm to children,” says a citizen petition filed with the agency.

“Despite the widespread—and rapidly growing—use of these drugs in this population [of children with the distress of gender dysphoria], and despite serious known and potential risks from these drugs, this use has never been evaluated for safety and effectiveness by the FDA.”

The petitioners include child and adolescent psychiatrist Dr Miriam Grossman, paediatric endorcinologist Dr Quentin van Meter and the groups Genspect, Detrans Help, FAIR in Medicine and the Gender Dysphoria Alliance.

The webpage hosting the petition is open to public comment. The FDA acknowledged receipt of the petition on September 5.

“Puberty blockers, or gonadotropin-releasing hormone (GnRH) agonists, are a class of drugs that are FDA-approved for treating certain cancers, endometriosis, and, in pediatric populations, central precocious puberty. Brand name puberty blockers include Lupron Depot-PED, Supprelin LA, Fensolvi, Synarel, and Triptodur. These drugs suppress the release of sex-specific hormones—testosterone in males and estrogen in females. When given to children in the early stages of puberty, they delay sex-related changes normal to adolescent development, such as deepening voice in males and breast development in females.”—citizen’s petition to the FDA, September 2023

The petitioners urge the FDA to—

• commission the National Academies of Sciences, Engineering, and Medicine (NASEM) to undertake a transparent and unbiased systematic review of the evidence for trans puberty blocker drugs • issue requests for long-term registry studies of the children given trans puberty blockers, given that long-term data “is critically important and sorely missing” • create a webpage disclosing the known and potential risks of off-label puberty blockade to “help to counter widespread confusion and misinformation about this use”

“Many in the medical profession and the media continue to represent the off-label use of puberty blockers as ‘well established’ and ‘lifesaving’,” the petition says.

“While the FDA has taken an aggressive stance against medical misinformation in other contexts, it has done nothing to counter these misrepresentations.

“What is most concerning is that, because puberty blockers are not FDA-approved in children with gender dysphoria, there is no demonstrated benefit of the drugs to justify these risks.

“This is why Sweden, Finland, the UK, Norway and other countries have all turned against the use of puberty blockers and other medical interventions as a front-line treatment of gender dysphoria, recognizing this use as experimental.

“The [American] public deserves the truth from its government about the potential harms of these drugs and the lack of established benefit.”

Puberty blockers are used off-label for gender dysphoria internationally, although brand names may vary from country to country.

Misinformation

“The FDA can address the misinformation surrounding the off-label use of puberty blockers in children by commissioning a systematic review of existing peer-reviewed studies by NASEM with the goal of developing an authoritative assessment of the evidence,” the petition says.

The citizen’s petition says the gender-affirmative treatment model used in the United States lacks the safeguards imposed by the Amsterdam gender clinic which in the late 1990s pioneered the use of puberty blockers followed by cross-sex hormones and surgery.

“Because of the prevalence of the affirmative model in the US, the number of children with gender dysphoria receiving puberty blockers has also risen sharply, more than doubling between 2017 and 2021,” the petition says.

“These drugs are known to interfere with bone development and fertility (when followed by cross-sex hormones) and serious concerns exist about their effect on long-term bone health and neurocognitive development.

“What is most concerning is that this [poorly understood] safety profile is currently tolerated in drugs prescribed to children for which the benefit is highly uncertain.”

The petition notes the vulnerability of dysphoric children, who have “higher rates of other psychological and developmental conditions, including autism, eating disorders and depression.”

“US District Court judges have been asked to compel the FDA to reveal what it knows about the off-label use of puberty blocker drugs by gender clinicians.”—news report, Gender Clinic News, 16 March 2023

This week’s citizen petition also calls upon the FDA to warn drug companies and health providers of the consequences of unlawful promotion of puberty blockers for children with dysphoria.

“Puberty blockers have been marketed directly to teenagers with promotions that characterize the drugs as a safe way to ‘put puberty on hold,’ without disclosing any of the required risk information,” the petition says.

“For example, a Planned Parenthood ad that first aired in 2022 depicts two cartoon teenagers speaking directly to potential users, stating—

‘[p]uberty blockers are safe and can give you more time to figure out what feels right for you, your body, and your gender identity,’ and ‘[y]our gender identity is real. You should be the one to decide what changes you want to make to your body’

The petition says, “Pharmaceutical companies that promote their drugs for off-label uses have paid multi-million-dollar settlements to avoid civil and criminal judgments.

“But the potential for harm to users doesn’t depend on who runs the ad: off-label promotions by practitioners that oversell the benefits of an off-label use and fail to disclose the risks have the same potential to deceive consumers.”

GCN has contacted the FDA for comment

==

Hopefully sanity will prevail.

[a-typical]

Are parabens really harmful?

Parabens are a class of chemicals that are commonly used as preservatives in cosmetics, personal care products, and some food products. There has been some concern in recent years that parabens may be harmful to human health, particularly in terms of their potential to act as endocrine disruptors, which are chemicals that can interfere with the body's hormonal system.

However, the scientific consensus on the safety of parabens is that they are generally safe for use in cosmetics and personal care products at the concentrations typically used. Regulatory agencies such as the US Food and Drug Administration (FDA) and the European Union's Scientific Committee on Consumer Safety (SCCS) have evaluated the available evidence and determined that parabens, when used as directed, do not pose a significant health risk to consumers.

That being said, some individuals may be sensitive or allergic to parabens, and may experience skin irritation or other adverse effects as a result. In addition, some people may choose to avoid parabens for personal or environmental reasons, as they are not biodegradable and can potentially accumulate in the environment over time.

Overall, while parabens have been the subject of some controversy, the weight of scientific evidence suggests that they are generally safe for use in cosmetics and personal care products, and are an effective means of preventing microbial growth and extending the shelf life of these products.

[afropuffsartstudios]

Keep your fur children safe this holiday season

(Not legal/medical advice)

[nationallawreview]

FDA Partners With Purdue University to Study Salmonella Risks

FDA has partnered with Purdue University and Indiana produce industry stakeholders to launch an environmental microbiology study to better understand the ecology of human pathogens, focusing on assessing risks related to Salmonella in the environment. The study is intended to develop a better understanding of the source of pathogens, their persistence, and how they transfer through the growing…

[head-post]

Coca-Cola recalls over 13,000 cases of “zero sugar” lemonade

Coca-Cola recalled 13,151 cases of Minute Maid Zero Sugar Lemonade after mislabelling on containers, according to the Food and Drug Administration (FDA), The Independent reported.

This came after cans of regular Minute Maid lemonade were put into cases labelled Minute Maid Zero Sugar Lemonade. The two types of lemonade differ greatly in ingredients: one can of Minute Maid Lemonade contains 40 grams of total sugar, 50 mg of sodium and 150 calories, whereas Zero Sugar Lemonade contains zero grams of total sugar, 50 mg of sodium and only five calories.

The recalled product was shipped to retail shops in Indiana, Kentucky and Ohio. However, the FDA clarified that the cases of lemonade were no longer in the shops.

No impacted product remains in the market, and all recall activities in those markets are complete.

To find out if their purchase was recalled, customers could look for the codes FEB1725CNA and FEB1725CNB on the packaging of the lemonade cases.

On 10 October, the recall was classified as a Class II. It is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

However, there has been an increase in the number of food recalls over the past year. In 2023, the FDA issued 506 recalls, the highest number of reports in five years, according to Sedgwick Brand Protection’s 2024 recall report. From 2022 to 2023, the number of FDA recalls increased 19.6 percent.

Last month, HP Hood LLC, which owned the lactose-free brand, announced a voluntary recall with the FDA over concerns about possible contamination with an almond allergen.

This issue was discovered as a result of routine maintenance programs which revealed the potential for trace amounts of almond.

Read more HERE

[xtruss]

Food and Drug Administration (FDA) Approves the First New Schizophrenia Drug in Decades

— By Alice Park | September 27, 2024

Steve Belkowitz (Bristol Myers Squibb)

No new treatments for schizophrenia have been approved in nearly three decades, but that changed on September 26, when the U.S. Food and Drug Administration (FDA) approved Cobenfy for the psychiatric disorder.

Developed by Karuna Therapeutics, which was subsequently acquired by Bristol Myers Squibb, the drug works in an entirely different way from existing medications for schizophrenia, which is building excitement and enthusiasm among doctors and patients alike.

How Scientists Developed The New Drug

While schizophrenia treatments primarily target the dopamine neurotransmitter system in the brain, Cobenfy goes after a different one, the cholinergic system, through muscarinic receptors. Decades ago, scientists at Eli Lilly had studied the muscarinic system as a possible treatment for Alzheimer’s disease, since manipulating it seemed to reduce some of the symptoms of Alzheimer’s-related psychosis that some patients develop. The company's researchers also serendipitously learned that a compound they developed to activate the system also improved symptoms of schizophrenia. But cells in many parts of the body—the brain, but also the bladder, gut, salivary glands, eyes, and heart—contain receptors for the muscarinic system, which meant it was challenging to selectively target just those in the brain and not elsewhere. Because the compound, called xanomeline, caused wide-ranging side effects, Lilly's researchers shelved further study on it.

Andrew Miller, co-founder of Karuna, became intrigued by this research and tried to figure out how to activate the muscarinic system in the brain while tamping it down elsewhere in the body. He and his team tested 7,000 compounds and eventually combined xanomeline with a drug that had been approved by the FDA in the 1970s for treating overactive bladder, to suppress muscarinic activity elsewhere in the body. "It's a pretty out-of-the-box approach," says Miller. The overactive bladder drug "has nothing to do with psychiatry," he said. Combining it with a serendipitous discovery of xanomeline "didn't fit the traditional model of innovative drug discovery." But it worked.

What Studies Have Found

In a study the company published last December in the journal Lancet, the researchers reported that the combination—now called Cobenfy but then called KarXT—helped to significantly reduce symptoms of schizophrenia such as hallucinations, delusions, paranoia, social withdrawal, and a loss of motivation compared to a placebo. Those data were part of the application that the company submitted to the FDA for approval.

Bristol Myers Squibb acquired Karuna in 2023 largely based on these encouraging results. “When we looked at the available neuroscience and neuropsychiatric assets out there, we didn’t want the next dopamine agonist or antagonist in the marketplace, which all of the physicians have [already] seen,” says Adam Lenkowsky, chief commercialization officer for Bristol Myers Squibb. “We wanted a truly revolutionary asset, one with a different mechanism: a first-in-class, best-in-category asset we think could transform the space.”

Samit Hirawat, chief medical officer at Bristol Myers Squibb, says that not only does Cobenfy address schizophrenia in an entirely new way, but its approach could be used for other neurological conditions as well. "The breadth of applicability of this medicine is what attracted us.”

Dr. Rishi Kakar, chief scientific officer at Segal Trials who led several studies on Cobenfy, says that “the uniqueness of the mechanism of action differentiated this medication from everything else we had so far, and truly caught my eye right off the bat.” Kakar—a psychiatrist who treats patients as well as conducts research—says that historically, only about 40% of people with schizophrenia respond to dopamine-based treatments, and the other 60% who may respond often stop taking their medications because of intolerable side effects, which can include uncontrolled muscle movements, dizziness, fainting, and weight gain.

The trials included patients who were hospitalized for acute schizophrenia and randomly assigned to receive Cobenfy—as a pill taken twice a day—or a placebo for five weeks. In order to reflect the real-world population of patients, some had been taking existing medications but stopped because of the side effects, or weren’t compliant. All patients went through a wash-out period of up to two weeks to ensure any measurements of their outcomes during the study were due solely to Cobenfy or placebo. Patients received escalating doses of the drug, and prescribing doctors were able to adjust dosages for their patients depending on their symptoms.

The studies documented a significant reduction in overall symptoms of schizophrenia in the patients receiving Cobenfy compared to placebo. “My viewpoint is that [this difference] can mean someone can potentially carry on a better life by having symptom control,” says Kakar.

What Else To Know About Cobenfy

The FDA approved Cobenfy as a monotherapy—meaning it is meant to be taken alone, without other medications—but more studies will be needed to see how the medication works in combination with existing treatments, and what the benefits and risks are of combining them. “I think many clinicians are going to try this as a first-time pharmacological option, because they will find that the reduction in symptoms is fairly robust,” says Kakar. “From what I saw, it has true value for the unmet need we have.” Lenkowsky says Bristol Myers Squibb is conducting a trial studying Cobenfy in combination with dopamine-based medications that will yield results in about a year.

In contrast to the existing dopamine-based treatments, the side effects of Cobenfy reported by the volunteers in the studies were mostly mild to moderate, involving nausea and gastrointestinal distress, and tended to lessen with time. The label also alerts patients that the drug is associated with urinary retention, increased heart rate and swelling in the face in rare cases; the medication is not recommended for people with a history of liver or kidney disorders.

Bristol Myers Squibb is continuing to study the drug for its longer term effects, as well as to understand and potentially guide doctors on how to adjust doses for patients as their symptoms change over time. The success in schizophrenia patients may lead to other uses of the drug in other conditions as well. “Neuropsychiatry is at the cusp of bringing an explosion of new medicines, and Cobenfy is the start of a pipeline of potential products,” says Hirawat. The company is currently studying the drug in Alzheimer’s-related psychosis, and next year plans to start late-stage trials investigating whether it can improve bipolar mania, Alzheimer’s-associated agitation, and Alzheimer’s-associated cognitive impairment. In 2027, the company hopes to begin trials in people with autism.

How Much Will Cobenfy Cost?

According to a Bristol Myers Squibb spokesperson, the wholesale cost for a month's supply will be $1,850. Depending on people's insurance coverage, that cost could be lower for individual patients. Bristol Myers Squibb estimates that 80% of people with schizophrenia in the U.S. have insurance coverage either through Medicare or Medicaid.