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Drug Trials Snapshot: COBENFY

HOW TO USE THIS SNAPSHOT

The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:

Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the COBENFY Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

COBENFY (xanomeline tartrate and trospium chloride)
co-BEN-fee 
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Original Approval date: September 26, 2024


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, and is used for the treatment of schizophrenia in adults.

How is this drug used?

COBENFY is given as capsules by mouth twice daily.

Who participated in the clinical trials?

The FDA approved COBENFY based on evidence from two clinical trials of 470 adult patients with schizophrenia. The trials were conducted at 39 sites in the United States and Ukraine. There were 425 trial participants from the United States.

The efficacy of COBENFY (which is a measure of how well the drug works) was evaluated in two clinical trials for 470 patients with schizophrenia, and safety was assessed in the two trials in a total of 504 patients with schizophrenia who received at least one dose of COBENFY. The same trials were used to assess efficacy and safety. The number of patients representing efficacy findings differs from the number of patients representing safety findings due to different pools of study participants analyzed for efficacy and safety.

How were the trials designed?

COBENFY was evaluated in two clinical trials of 470 patients with schizophrenia.

In the trials, patients were randomly assigned to receive COBENFY or placebo, and neither patients nor care providers knew which treatment was given during the trial. Symptoms of schizophrenia were measured using a clinician-administered measure of schizophrenia symptoms called the Positive and Negative Syndrome Scale (PANSS). The benefit of COBENFY was assessed in both trials by determining the improvement in schizophrenia symptoms (the difference in PANSS scores before and after five weeks of treatment).

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many male and female patients were enrolled in the clinical trials used to evaluate the efficacy of COBENFY. 

Figure 1. Baseline Demographics by Sex, Efficacy Population

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 352 (75%) male patients and 118 (25%) female patients participated in the clinical trial.

Source: Adapted from FDA Review of Clinical Data

Figure 2 summarizes the percentage of patients by race who were enrolled in the clinical trials used to evaluate the efficacy of COBENFY. 

Figure 2. Baseline Demographics by Race, Efficacy Population

Pie chart summarizing how many White, Black or African American, Asian, and other or not reported patients were in the clinical trial. In total, 145 (30.9%) White patients, 319 (67.9%) Black or African American patients, 3 (0.6%) Asian patients, and 3 (0.6%) other or not reported patients participated in the clinical trial.

Source: Adapted from FDA Review of Clinical Data

Figure 3 summarizes the percentage of patients by race who were enrolled in the clinical trials used to evaluate the efficacy of COBENFY. 

Figure 3. Baseline Demographics by Race, Efficacy Population

Pie chart summarizing how many patients by age were in the clinical trial. In total, 224 (48%) patients younger than 45 years of age and 246 (52%) patients 45 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review of Clinical Data

Figure 4 summarizes the percentage of patients by ethnicity who were enrolled in the clinical trials used to evaluate the efficacy of COBENFY. 

Figure 4. Baseline Demographics by Ethnicity, Efficacy Population

Pie chart summarizing how many Hispanic, not Hispanic, and not reported patients were in the clinical trial. In total, 51 (10.9%) Hispanic or Latino patients, 417 (88.7%) not Hispanic or Latino patients, and 2 (0.4%) not reported patients participated in the clinical trial.

Source: Adapted from FDA Review of Clinical Data

What are the benefits of this drug? 

In two trials, patients with schizophrenia who were given COBENFY achieved more improvement of schizophrenia symptoms after five weeks of treatment than patients given placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age? 

  • Sex: COBENFY worked similarly in both males and females. 
  • Race: COBENFY worked similarly in White and Black or African American participants. However, the number of participants in other races was limited; therefore, differences in how well COBENFY worked in other races could not be determined.
  • Age: Differences in how COBENFY worked in ages older than 65 could not be determined because all participants were adults younger than 65 years old.

What are the possible side effects?

The most common side effects seen in the clinical studies were nausea, dyspepsia, constipation, vomiting, high blood pressure, abdominal pain, diarrhea, increased heart rate, dizziness, and heartburn (also known as gastrointestinal reflux disease [GERD]).

Were there any differences in side effects among sex, race, and age?

  • Sex: The occurrence of side effects with COBENFY was similar in both males and females, although females reported slightly higher rates of nausea and constipation.
  • Race: The occurrence of side effects with COBENFY was similar in White and Black or African American participants, although patients who were White reported slightly higher rates of nausea and vomiting. The number of participants in other races was limited; therefore, differences in how well COBENFY was tolerated in other races could not be determined.
  • Age: Differences in side effects for COBENFY in ages older than 65 could not be determined because all participants were adults younger than 65 years old.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.

COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.

EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.

PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.

SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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