What side effects are associated with this type of intervention?

Common treatments for sleep apnea include CPAP therapy, orexin receptor antagonists like daridorexant, and combination drug therapies. CPAP therapy, while effective, often has side effects such as nasal congestion, dry mouth, and discomfort leading to low adherence. Orexin receptor antagonists, such as daridorexant, have been associated with increased respiratory events and potential worsening of sleep apnea symptoms. Combination therapies, like atomoxetine with aroxybutynin, may cause adverse events, though specific side effects were not detailed. Overall, side effects can vary widely depending on the treatment modality.

What prior FDA approvals exist?

There are no specific mentions of FDA-approved selective orexin receptor agonists for the treatment of obstructive sleep apnea (OSA) in the provided context. However, the context does discuss the use of various pharmacologic agents for OSA, such as medroxyprogesterone and protriptyline, though these are not universally effective and have significant side effects. The context also highlights the need for more research to identify effective pharmacologic treatments for OSA. Danavorexton, being studied as a selective orexin receptor agonist, represents a novel approach in this area.

What other types of research exist?

Promising novel alternatives to Danavorexton for sleep apnea patients include nasal expiratory positive airway pressure (PAP), oral negative pressure devices, upper airway muscle stimulation, and bariatric surgery. These options are emerging as effective therapies and are expected to be significant in 2024.

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Danavorexton for Obstructive Sleep Apnea

Q: What is the mechanism of action of this treatment?

The most common treatments for Sleep Apnea include positive airway pressure (PAP) therapy, which keeps the airway open by providing a continuous stream of air, and oral appliances that reposition the jaw to maintain an open airway. Pharmacotherapy is an emerging field, with selective orexin receptor agonists like Danavorexton being studied for their potential to improve breathing by modulating the neural pathways that control wakefulness and muscle tone in the upper airway. This is particularly important for Sleep Apnea patients as it offers a potential alternative for those who cannot tolerate PAP therapy, addressing both the airway obstruction and the associated daytime sleepiness.

Phase 2

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The participant has an American Society of Anesthesiologists (ASA) Classification of II to III.

The participant is scheduled for abdominal surgery that will include at least 1 inpatient overnight stay.

Must not have

For the participant, immediate continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) use in the PACU is anticipated or planned.

The participant has uncontrolled hypertension or unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, myocardial infarction <3 months, severe valvular disease, or severe structural heart disease), severe heart failure, or any condition requiring a pacemaker or defibrillator.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Summary

This trial is testing if danavorexton can help people with sleep apnea breathe better after abdominal surgery. The study involves about 180 participants and will take place over several months.

Who is the study for?

This trial is for adults with a BMI of 18.5-50 who have moderate obstructive sleep apnea, based on recent sleep tests or high-risk scores from questionnaires. They must be scheduled for abdominal surgery requiring an overnight stay, general anesthesia, and post-surgery opioids. Excluded are those with recent major surgeries, chemotherapy, certain infections like HIV/HCV, uncontrolled diabetes or hypertension, severe heart issues, or anticipated ICU transfer.

What is being tested?

The study is testing whether Danavorexton can improve breathing in patients recovering from abdominal surgery under general anesthesia compared to a placebo. Participants will receive either the drug or placebo to assess its effectiveness in managing obstructive sleep apnea symptoms post-operation.

What are the potential side effects?

While specific side effects of Danavorexton aren't listed here, common medication-related side effects could include nausea, headache, dizziness or allergic reactions. The severity and type of side effects may vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a moderate to severe physical health status according to the ASA.

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I am scheduled for abdominal surgery that requires staying in the hospital overnight.

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I am scheduled for surgery that will require me to be put to sleep and have a breathing tube.

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I will need strong painkillers through an IV after my surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will need a CPAP or BiPAP machine right after surgery.

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I do not have uncontrolled high blood pressure or serious heart problems.

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I am scheduled to be moved to the ICU after surgery.

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I am scheduled for liver or kidney surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU)

Secondary study objectives

Number of Episodes of Respiratory Instability per Participant Within 120 Minutes in the PACU

Number of Participants with At Least One Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose DanavorextonExperimental Treatment1 Intervention

Participants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.

Group II: High Dose DanavorextonExperimental Treatment1 Intervention

Participants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Danavorexton

2022

Completed Phase 1

~50

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sleep Apnea include positive airway pressure (PAP) therapy, which keeps the airway open by providing a continuous stream of air, and oral appliances that reposition the jaw to maintain an open airway. Pharmacotherapy is an emerging field, with selective orexin receptor agonists like Danavorexton being studied for their potential to improve breathing by modulating the neural pathways that control wakefulness and muscle tone in the upper airway. This is particularly important for Sleep Apnea patients as it offers a potential alternative for those who cannot tolerate PAP therapy, addressing both the airway obstruction and the associated daytime sleepiness.

Pharmacologic treatment of obstructive sleep apnea.New frontiers in pharmacologic obstructive sleep apnea treatment: A narrative review.Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment.