Cobenfy's Role in Revolutionizing Schizophrenia Treatment: An Insider Perspective

Jelena Kunovac, MD, MS

On September 26, 2024, the US Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride), formerly known as KarXT, for the treatment of schizophrenia in adults. In doing so, this new agent represents the first medication for schizophrenia in more than 30 years with a novel mechanism of action.

Jelena Kunovac, MD, MS, co-founder and chief executive officer Redbird Research in Las Vegas, Nevada, and adjunct assistant professor in the Department of Psychiatry at the University of Nevada, Las Vegas, was involved in the clinical trials. In this video, she shares her excitement for the new agent and talks about what this approval means for the field of psychiatry, psychiatric clinicians, and patients. Hear her insider insights as well as what clinicians should be doing to prepare themselves and their patients for leveraging this medication.

"When you do so many clinical trials, a lot of them are [looking at] the same mechanism of action. The companies are just trying to bring something with a slightly different twist to something that already exists, and we're like, 'wow, you know, whatever'," Kunovac told Psychiatric Times. "But Karuna, which is the company that actually developed this medication, had a very different approach, and they were just so passionate and so enthusiastic about doing their best to execute a clinical trial in a way that we get the best possible idea whether this medication works."

"What excited me being the part of the group of the people who thought that we can together make the difference in bringing this medication to the market for patients who struggle with schizophrenia," she explained.

When asked about what makes this medication and this approval special, Kunovac pointed to its novel mechanism of action. "Whether it's 30 something years or whether it's in essence, 70 years, it is a different mode of action than any current drugs, and has a different adverse event profile."

"Who is the right patient for this? I think any patient is the right patient. This medication is not approved just for the treatment of schizophrenia, or for the treatment of treatment resistant schizophrenia, this medication is approved for the treatment of schizophrenia," she added. "So the patient who comes, you know, with an exacerbation of the symptoms could be a good patient, the patient who comes particularly with side effects that he or she doesn't tolerate, whether intolerable side effects, or bothersome side effects along the lines of the standard adverse events of antipsychotics (such as metabolic syndrome-related weight gain, increased cholesterol, increased blood glucose), or the patient who has a movement disorder, particularly tremor shakiness, restlessness, akathasia. Or the patient whose hormonal dysregulation, such as hyperprolactinemia due to taking the typical and atypical antipsychotics would be a good patient for this medication."

Kunovac had advice for clinicians interested in preparing themselves to prescribe Cobenfy to patients. "First, they have to familiarize themselves with the adverse events and understand what is the medication about—that it is consists of 2 different compounds," she said. "And in order to be able to explain to the patient what they're going to be taking, you have to know it yourself. So familiarize yourself with the medication and then with the adverse events of the medication, because, again, we don't have a perfect pill in psychiatry that's going to have only benefits and not adverse events. So being aware of gastrointestinal adverse events such as nausea, vomiting, diarrhea, potentially, constipation, is very important. Knowing about urinary retention as well increased heart rate. Those would be the thing that one needs to be aware of before prescribing this medication."

"I have been in touch with quite a few health care providers," Kunovac told Psychiatric Times. "And the excitement among the patients, the phone calls that are coming from the family members as some of the patients wanting to try this medication is through the roof. I actually have never seen—and, again, being involved in clinical trials for the last 20 years and pretty much being the part of any and every clinical trial that led to the approval of, I would say, 90% of psychotropic drugs that were approved with the last 15 years—I have never seen or heard of such an excitement as the excitement about Cobenfy."

At the time of this interview, Kunovac had participated in 525 clinical trials, most of which in the central nervous system space. She was the part of the EMERGENT clinical trials, for which she recruited and evaluated patients, and collaborated with the pharmaceutical company but did not participate as a employee of the company.

To learn more from Kunovac, watch the video. For more on this approval and other issues vital to psychiatry, visit psychiatrictimes.com and subscribe to our e-newsletters.