Karuna Therapeutics, a Japanese biopharmaceutical company, is experimenting with a new drug for schizophrenia. Researchers combined an older drug with another that reduces side effects.
A new drug for schizophrenia may come on the market next year. It is a much-needed medicine that can improve the quality of life of patients. The new drug would also have no side effects.
The latest data on the development of the drug has recently been released. The data reinforces the potential to provide progress for schizophrenia, a condition that affects about 0.7% of the world’s population.
Predecessor
A component of the treatment called xanomeline has been around since the early 1990s. At the time, it was used to treat cognitive and behavioral symptoms of Alzheimer’s disease and later schizophrenia.
Small studies show that the drug could have a clear effect on these symptoms, but it was pulled from development because people couldn’t tolerate the side effects. The problem was that the drug not only acted on receptors that transmit messages between nerve cells in the brain, but interacted with receptors all over the body, causing people who took it to feel nauseous and vomit.
Normally, the next step would have been to design a new molecule that retains the good parts of the drug but avoids the nasty side effects. However, Xanomeline entered the market when the currently available antipsychotic drugs were introduced. These mainly worked by inhibiting the dopamine signals in the brain. Because scientists were convinced that it would be useless to try to remove the bad aspects of xanomeline, companies ignored the drug.
Many years later, Karuna took a different tack. Instead of creating a new drug from scratch, they combined it with a drug that could reduce side effects. It turned out that such a drug already existed. An overactive bladder syndrome drug called trospium blocks muscarinic receptors outside the brain, limiting the effects of xanomeline largely to the brain itself.
Karuna medicine
New data provides evidence that the approach works. Schizophrenia encompasses a range of symptoms and the study achieved its primary goal of showing that the Karuna drug can reduce paranoia, delusions and hallucinations. It also avoids the weight gain or drowsiness associated with all currently available schizophrenia drugs.
Yet there is one more side effect of the new drug: the patients who took the drug had increased blood pressure. Still, the side effect didn’t cause people to drop out of the experiment. The size of the effect also decreased after a certain period. Karuna is currently investigating the matter in a separate safety study.
In this study, the drug also had no statistically significant effect on the so-called “negative symptoms” of schizophrenia. Those are qualities that are diminished in the patients compared to people without the disease, such as emotional and verbal engagement with the world. But that doesn’t mean the drug won’t receive approval from the U.S. Food and Drug Administration (FDA), which is expected in the second half of 2024.
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