Bristol Myers Squibb and TV Host Gail Simmons Tackle Stigma in Schizophrenia with New Initiative Spotlighting the Power of Support and Connection
The initiative features the perspectives of adults living with schizophrenia and taking COBENFY™ (xanomeline and trospium chloride), their care partners and a psychiatrist
Bristol Myers Squibb (NYSE:BMY) today announced the launch of its COBENFY Connections™ initiative in partnership with culinary expert, TV host and author Gail Simmons.* Launching on World Mental Health Day, the initiative features real stories from people affected by schizophrenia, including Simmons, who shares her perspective through her brother Alan's journey with the condition. The initiative aims to shift the narrative around schizophrenia, one of the most misunderstood and stigmatized mental illnesses, through honest conversation. Sharing her family's experience and inviting others to do the same, Simmons emphasizes how connection and community can help people living with schizophrenia feel seen, supported, and hopeful, as well as the importance of finding the treatment that's right for them.
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Gail Simmons, culinary expert, TV host and author. Photo: Bristol Myers Squibb
Known for bringing people together around the table, Simmons recently hosted an intimate gathering with people living with schizophrenia and taking COBENFY™ (xanomeline and trospium chloride), along with their care partners and a psychiatrist. The gathering provided a rare, yet important space for open conversations about living with schizophrenia, highlighting how advocating for yourself and your treatment goals, exploring options, and finding a medicine that works for you can make a real difference.
"My older brother's diagnosis with schizophrenia affected my family in so many ways, and we struggled to find the right medicines and resources," said Simmons. "Hearing others share their experiences was an inspiring reminder of the power of community. Through COBENFY Connections, I hope to empower others to open up and explore what's possible with the right support and treatment."
The initiative also features the perspectives of Avary and Chanel, both living with schizophrenia and taking COBENFY, and their care partners.** COBENFY is an oral prescription medicine used to treat adults with schizophrenia. It is not known if COBENFY is safe and effective in children. See additional Important Safety Information below.
"We often take sitting at the table with loved ones for granted. Partnering with Gail let us create a space where people living with schizophrenia and their families could connect and share their experiences," said Carlos Dortrait, senior vice president of Neuroscience Commercialization at Bristol Myers Squibb. "Our goal is simple: to create more spaces where experiences are shared, courage is celebrated, and stories like those of Chanel and Avary bring hope—showing how connection, community, and the right treatment can make a difference."
Learn more about COBENFY Connections by visiting connections.bms.com.
Please see Important Safety Information for COBENFY below, including serious and most common side effects.
*Gail does not have schizophrenia and is not taking COBENFY. Gail's brother Alan did not take COBENFY.
**Gail, Avary, Ashleigh, Chanel, Fines and Dr. Patricia Ares-Romero were compensated for their time.
About Schizophrenia
Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels and behaves. There are three main symptom domains of schizophrenia, which include positive symptoms (e.g., hallucinations, delusions, disordered thinking and speech), negative symptoms (e.g., lack of motivation, lack of emotional expression/flat affect, social withdrawal) and cognitive dysfunction (e.g., impaired attention, deficits in memory, concentration and decision-making). The symptoms of schizophrenia can affect all areas of people's lives, making it difficult to maintain employment, live independently and manage relationships. Schizophrenia affects nearly 24 million people worldwide, including 2.8 million people in the United States, and is one of the top 15 leading causes of disability worldwide.
About COBENFY™ (xanomeline and trospium chloride)
COBENFY™ (xanomeline and trospium chloride), formerly KarXT, is an oral medication for the treatment of schizophrenia in adults. It is not known if COBENFY is safe and effective in children. COBENFY combines xanomeline, a dual M1- and M4-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist that does not appreciably cross the blood-brain barrier, primarily confining its effects to peripheral tissues. While the exact mechanism of action of COBENFY is unknown, its efficacy is thought to be due to the agonist activity of xanomeline at M1 and M4 muscarinic acetylcholine receptors in the central nervous system.
INDICATION
COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
COBENFY is contraindicated in patients with:
- urinary retention
- moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment
- gastric retention
- history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride.
- untreated narrow-angle glaucoma
WARNINGS AND PRECAUTIONS
Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), diabetic cystopathy) may be at increased risk of urinary retention.
COBENFY is contraindicated in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment.
In patients taking COBENFY, monitor for symptoms of urinary retention, including urinary hesitancy, weak stream, incomplete bladder emptying, and dysuria. Instruct patients to be aware of the risk and promptly report symptoms of urinary retention to their healthcare provider. Urinary retention is a known risk factor for urinary tract infections. In patients with symptoms of urinary retention, consider reducing the dose of COBENFY, discontinuing COBENFY, or referring patients for urologic evaluation as clinically indicated.
Risk of Use in Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of COBENFY, compared to patients with normal hepatic function, which may result in increased incidence of COBENFY-related adverse reactions.
COBENFY is contraindicated in patients with moderate or severe hepatic impairment. COBENFY is not recommended in patients with mild hepatic impairment.
Assess liver enzymes prior to initiating COBENFY and as clinically indicated during treatment.
Risk of Use in Patients with Biliary Disease: In clinical studies with COBENFY, transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage.
COBENFY is not recommended for patients with active biliary disease such as symptomatic gallstones. Assess liver enzymes and bilirubin prior to initiating COBENFY and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated.
Discontinue COBENFY in the presence of signs or symptoms of substantial liver injury such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values.
Decreased Gastrointestinal Motility: COBENFY contains trospium chloride. Trospium chloride, like other antimuscarinic agents, may decrease gastrointestinal motility. Administer COBENFY with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Use COBENFY with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.
Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with COBENFY and trospium chloride, a component of COBENFY. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue COBENFY and initiate appropriate therapy and/or measures necessary to ensure a patent airway. COBENFY is contraindicated in patients with a history of hypersensitivity to trospium chloride.
Risk of Use in Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of COBENFY. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, COBENFY should only be used if the potential benefits outweigh the risks and with careful monitoring.
Increases in Heart Rate: COBENFY can increase heart rate. Assess heart rate at baseline and as clinically indicated during treatment with COBENFY.
Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, a component of COBENFY, is substantially excreted by the kidney. COBENFY is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure of trospium chloride is higher in patients with moderate and severe renal impairment. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate and severe renal impairment.
Central Nervous System Effects: Trospium chloride, a component of COBENFY, is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported with trospium chloride, including dizziness, confusion, hallucinations, and somnolence. Monitor patients for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how COBENFY affects them. If a patient experiences anticholinergic CNS effects, consider dose reduction or drug discontinuation.
Most Common Adverse Reactions (≥5% and at least twice placebo): nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.
Use in Specific Populations:
- Moderate or Severe Renal Impairment: Not recommended
- Mild Hepatic Impairment: Not recommended
Pregnancy and Lactation: There is a pregnancy exposure registry that monitors outcomes in women exposed to psychiatric medications, including COBENFY, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling 1-866-961-2388 or visiting https://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/.
There are no available data on COBENFY use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Additionally, there are no data on the presence of xanomeline or trospium in human milk, the effects on the breastfed infant, or the effects on milk production. However, xanomeline and trospium are present in animal milk, suggesting they may also be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COBENFY and any potential adverse effects on the breastfed infant from COBENFY or the underlying maternal condition.
COBENFY (xanomeline and trospium chloride) is available in 50mg/20mg, 100mg/20mg, and 125mg/30mg capsules.
Please see U.S. Full Prescribing Information, including Patient Information.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
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