Some people who took a new schizophrenia drug for a year experienced improvement with only minor side effects, but many dropped out of the study, the company announced Thursday.
This result highlights the difficulty of treatment. schizophrenia, severe mental illness It can cause people to hear voices, feel paranoid, and distance themselves from others. High dropout rates are typical of schizophrenia drug studies.
Finding an effective drug can be a long ordeal punctuated by crises and hospitalizations. Side effects of existing medications (weight gain, tremors, restlessness) may cause some people to stop taking the medication and relapse.
Doctors have high hopes for Cobenfi, which was approved in September and works differently in the brain than other schizophrenia drugs. Cobenfy’s main ingredient, xanomeline, does not block dopamine receptors, but acts on another receptor that indirectly blocks dopamine release.
Cobenfy also contains trospium, which blocks some side effects. The most common are nausea, vomiting, and indigestion. In contrast to the weight gain seen with other schizophrenia drugs, people lost several pounds when taking Bristol-Myers Squibb’s Cobenfi.
Dr. John Crystal of Yale University has led research into other schizophrenia drugs but was not involved in the new study. He noted that only 10 to 20 percent of participants in the new study dropped out due to side effects.
“That’s pretty good,” he said, noting that fewer or milder side effects could mean longer treatment times. That could mean fewer problems related to untreated mental illness, such as drug use, homelessness, and unemployment.
So why do some patients stay on treatment while others stop? Crystal says it’s important for doctors to understand more about this before they start prescribing this drug. He said it would happen.
The Food and Drug Administration approved Cobenfi based on two encouraging five-week company-sponsored trials and other safety data. The latest results, presented Thursday at a psychology conference in Boston, come from two long-term studies and provide a more complete picture.
In one study that focused on critically ill patients, 78% dropped out, with only 35 remaining in the final analysis. The other focused on more stable people, with 51% dropping out of the study, leaving 283 people on the drug for a year.
Dr. Greg Mattingly of Washington University School of Medicine in St. Louis said that in studies of schizophrenia, “we don’t see anything higher or lower than what we normally see.” Mr. Mattingly is a consultant and researcher for Bristol-Myers Squibb.
