FDA Approves Bristol Myers Squibb’s New Antipsychotic Drug Cobenfy for Schizophrenia Treatment

The U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride), for the treatment of schizophrenia, a chronic mental health disorder. Developed by Karuna Therapeutics and now owned by Bristol Myers Squibb, Cobenfy works by targeting cholinergic receptors unlike traditional antipsychotic medications that target dopamine receptors.

This marks a significant departure from the conventional approach to schizophrenia treatment, according to the FDA. Schizophrenia is a debilitating mental illness characterized by hallucinations, delusions, disorganized thinking, and behavioral disturbances. Those affected often struggle to maintain a grasp on reality and may experience cognitive impairments.

Globally, about 24 million people are living with schizophrenia, including 2.8 million in the U.S., where it ranks as one of the top 15 causes of disability. Tragically, the condition is linked to a shortened lifespan, with approximately 5% of patients dying by suicide, the FDA noted.

The approval of Cobenfy is seen as a hopeful development for individuals affected by schizophrenia. “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that profoundly impacts quality of life,” said Tiffany Farchione, Director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research. “This drug offers the first new approach to treating schizophrenia in decades, providing an alternative to previously prescribed antipsychotic medications.”

The effectiveness of Cobenfy was demonstrated in two clinical studies. Over a five-week period, patients’ symptoms were measured using the Positive and Negative Syndrome Scale (PANSS), a 30-item tool used to assess schizophrenia symptoms. Results showed that patients treated with Cobenfy experienced a significant reduction in symptoms compared to those on a placebo.

However, the FDA highlighted several side effects associated with the drug, including nausea, constipation, vomiting, increased heart rate, and diarrhea. Due to the risk of severe side effects, the agency advised against prescribing Cobenfy to patients with urinary retention, kidney, or liver disease.

Earlier this year, in March, Bristol Myers Squibb acquired Karuna Therapeutics for $14 billion, gaining exclusive rights to KarXT (Cobenfy). The company plans to launch the drug by the end of October, with a monthly cost of $1,850, or around $22,500 annually, according to Reuters.

Sales are projected to reach $2.5 billion in the U.S. by 2030. Bristol aims to provide insurance coverage for 80% of patients within the first 12 to 18 months of the drug’s release. To further assist patients, Bristol has introduced a support program called “COBENFY Cares.”

Onions can bring down sugar levels in Diabetes patients

Diabetes is an ailment that cannot curbed entirely but controlled. The patients of diabetes often experience spiking blood sugar levels due to insufficient insulin generated in the body.

While type-1 diabetes is visible since childhood, diabetes type-2 affects the middle aged people and mostly those in their 50s or 60s. In India too, it’s the most common disease affecting millions of people.

While doctors recommend a low-carbohydrate diet besides regular exercise and weight management to improve insulin sensitivity, some experiments have proved that onions can help reduce the diabetes.

The findings presented at the 97th annual meeting of the Endocrine Society in 2015 show that the extract of an onion can lower blood sugar levels. It was found more effective when given with the common diabetes drug metformin.

“Onion is cheap and available and has been used as a nutritional supplement,” said lead investigator Anthony Ojieh of Delta State University in Nigeria. “It has the potential for use in treating patients with diabetes.”

Ojieh and his colleagues gave metformin and varying doses of onion extract—200, 400 and 600 milligrams per kilograms of body weight daily to see if it would enhance the drug’s effect. Onion extract reportedly lowered the total cholesterol level in diabetic rats, with the two larger doses again having the greatest effects.

Also they found that the onion extract led to an increase in average weight among nondiabetic rats but not diabetic rats. Further, onion extract lowered cholesterol levels.

“Onion is not high in calories. However, it seems to increase the metabolic rate and, with that, to increase the appetite, leading to an increase in feeding,” Ojieh said.

However, for diabetes management, there is no one-size-fits-all approach. Diet is a key and doctors suggest:

  • Consume daily lots of fruits and vegetables
  • Avoid carbs and sugar
  • Eat lean proteins such as chicken and fish
  • Take nuts and cereals frequently
  • Legumes and whole grains should be part of your daily diet.

[Disclaimer: Suggestions are for general information and should not be construed as professional medical advice. Please consult your doctor before making any changes to your diet.]

Sclerosis Medicine can help Fight Drug-Resistant Bacteria

A surprising discovery shows that a widely used and 20-year-old medicine used to treat multiple sclerosis can also beat a type of multi-resistant bacteria for which there are currently only a few effective drugs.

Encountering bacteria with innocent names such as Pseudomonas aeruginosa and Enterobacteriaceae can lead to hospitalisation and – in a worst-case scenario – can also be life-threatening. The bacteria, which cause infections such as pneumonia, frequently develop multi-resistance towards classic antibiotics.

Researchers from Aarhus University have discovered that a drug known as glatiramer acetate, which is normally used for treating the disease multiple sclerosis, has a hitherto unknown effect on obstinate bacteria.

Laboratory experiments have shown that the drug kills half of the Pseudomonas bacteria in specimens from patients with cystic fibrosis who are often exposed to the bacteria in the lungs.

The research results have recently been published in the scientific journal Scientific Reports.The discovery is good news at a time where multi-resistant bacteria are a growing problem.

According to a British survey commissioned by the British government, in 2050 resistant bacteria will all-in-all kill more people around the world than cancer. Neither the pharmaceutical industry or researchers have so far succeeded in developing new types of antibiotics that can beat the bacteria following classic strategies for the development of new medicines.

The research project is part of a new global movement within the development of medicine that focuses on medicine recycling or, as it is also called, repurposing. This is where researchers and companies test already approved medicines or substances on other diseases or functions of human biology than those they were originally developed for.

The discovery also opens up for a new view of multiple sclerosis.

“The results give us greater knowledge about how the drug works on sclerosis patients and indicates at the same time that bacteria might be part of the problem with the disease. This is also indicated by some studies,” says Thomas Vorup-Jensen.

Aarhus University is collaborating with Aarhus University Hospital, Imperial College London, UK, Harvard Medical School, Boston, USA and the British pharmaceutical company Cycle Pharmaceuticals, who specialise in the recycling of medicine.