A Potential New Hope for Patients with Chronic CNS Symptoms – Haduvio™
Are you suffering from or caring for someone with symptoms associated with chronic neurologically mediated conditions?
Trevi is developing the investigational therapy Haduvio™ (nalbuphine ER) as an oral treatment for a range of indications for which patients have few, if any, treatment options. With its dual mechanism of action, Haduvio™ has the potential to significantly improve the quality of life of patients with a broad range of neurologically mediated conditions.
For what indications is Haduvio™ being developed?
We are currently investigating the use of Haduvio™ in patients with:
- Pruritus in Prurigo Nodularis – a chronic, intensely pruritic dermatological condition characterized by the presence of pruriginous lesions such as papules, nodules or plaques, which may be associated with excoriations and ulcerations.
- Pruritus in Chronic Liver Disease – a common complication of chronic cholestatic liver diseases such as primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC); patients develop severe whole-body itch, an intense, intractable, debilitating condition that significantly disrupts patients’ daily activities and sleep, and consequently impairs their quality of life.
- Chronic Cough related to Idiopathic Pulmonary Fibrosis (IPF) – IPF is a rare, chronic, progressive lung disease, characterized by scarring and thickening of lung tissue; most patients diagnosed with IPF suffer from a dry, non-productive chronic cough that interrupts their daily living and significantly contributes to poor quality of life.
And are planning future clinical trials in patients with:
- Levodopa-induced Dyskinesia (LID) in patients with Parkinson’s Disease – involuntary / motor complications resulting from levodopa therapy.
What resources are available to patients suffering from these conditions?
- National Institutes of Health
- American Academy of Dermatology
- European Academy of Dermatology and Venereology
Pruritus in Chronic Liver Disease
- American Association for the Study of Liver Diseases
- The European Association for the Study of the Liver
Chronic Cough related to Idiopathic Pulmonary Fibrosis (IPF)
- American Lung Association
- The European Idiopathic Pulmonary Fibrosis and Related Disorders Federation (EU-IPF)
Levodopa-induced Dyskinesia (LID) in patients with Parkinson’s Disease
How can I stay informed on progress being made with Haduvio™?
How can I get involved in a clinical trial?
Is expanded access available?
Randomized trials to assess the safety and efficacy of NAL ER are ongoing. The goal of these studies is to understand the potential benefits, risks, and appropriate use(s) of NAL ER. In order to participate, patients entering the clinical trials are required to meet specific criteria in order to protect their safety as well as the integrity of the trial. At this stage of development, Trevi considers that our current clinical trials provide the most appropriate path for patients to access the investigational medicine that we are developing. As such, expanded access outside of the ongoing clinical trials is not currently available.
Note: Haduvio™ is an investigational therapy and not yet approved for use.