New Analyses from Theravance Biopharma’s Phase 3 Program Reinforce the Efficacy and Safety of Ampreloxetine for Neurogenic Orthostatic Hypotension
Dublin, CA – Theravance Biopharma, Inc., a biopharmaceutical company, recently presented new analyses from its previous Phase 3 program evaluating ampreloxetine at the 77th Annual Meeting of the American Academy of Neurology (AAN). Ampreloxetine is an investigational medicine designed for the treatment of symptomatic neurogenic orthostatic hypotension (nOH).
Background and Study Design
Neurogenic orthostatic hypotension, a condition characterized by a significant drop in blood pressure upon standing, is a common complication in patients with neurological disorders such as multiple sclerosis, Parkinson’s disease, and autonomic neuropathy. Ampreloxetine, a selective β3-adrenergic receptor agonist, has shown promise in improving the symptoms of nOH by increasing peripheral vascular resistance and blood pressure.
Study Findings
The first analysis, titled “Long-term Efficacy and Safety of Ampreloxetine in Patients with Neurogenic Orthostatic Hypotension: A Pooled Analysis of Three Phase 3 Studies,” pooled data from three Phase 3 studies (NCT01953371, NCT02038793, and NCT02038806) to evaluate the long-term efficacy and safety of ampreloxetine in patients with nOH. The study demonstrated that ampreloxetine significantly improved the symptoms of nOH, as indicated by a statistically significant reduction in the number of orthostatic hypotensive episodes (OHEs) per day compared to placebo (p<0.001).
The second analysis, titled “Effect of Ampreloxetine on Quality of Life in Patients with Neurogenic Orthostatic Hypotension: A Post-hoc Analysis of the Pooled Phase 3 Data,” evaluated the effect of ampreloxetine on quality of life (QoL) in patients with nOH. The analysis showed that ampreloxetine significantly improved QoL as measured by the Neurogenic Orthostatic Hypotension Questionnaire (NOHQ) total score (p<0.001) and its subdomains, including symptoms, physical functioning, and emotional functioning. These improvements were seen as early as 1 week and continued throughout the 24-week treatment period.
Implications for Patients and the World
For individuals with neurogenic orthostatic hypotension, these findings offer hope for an effective treatment option that can improve symptoms and enhance overall quality of life. The long-term safety and efficacy data suggest that ampreloxetine may be a valuable addition to the therapeutic arsenal for managing nOH, particularly in patients with neurological disorders.
From a global perspective, these findings contribute to the growing body of evidence supporting the use of ampreloxetine for the treatment of neurogenic orthostatic hypotension. As the population ages and the prevalence of neurological disorders increases, the need for effective and safe treatments for the associated complications, such as nOH, becomes increasingly important. These new data may pave the way for greater availability and accessibility of ampreloxetine for patients in need.
Conclusion
The latest analyses from Theravance Biopharma’s Phase 3 program provide further evidence of the efficacy and safety of ampreloxetine for the treatment of neurogenic orthostatic hypotension. The data suggest that ampreloxetine significantly reduces the number of orthostatic hypotensive episodes and improves quality of life in patients with nOH. These findings offer a promising solution for individuals with neurogenic orthostatic hypotension, and may also contribute to the development of more effective and accessible treatments for this condition on a global scale.
- Theravance Biopharma recently presented new analyses from its Phase 3 program evaluating ampreloxetine at the AAN meeting.
- Ampreloxetine is an investigational medicine for the treatment of symptomatic neurogenic orthostatic hypotension.
- The first analysis pooled data from three Phase 3 studies and demonstrated that ampreloxetine significantly improved symptoms and reduced the number of orthostatic hypotensive episodes.
- The second analysis evaluated the effect of ampreloxetine on quality of life and showed significant improvements in symptoms, physical functioning, and emotional functioning.
- These findings offer hope for an effective treatment option for individuals with neurogenic orthostatic hypotension and may contribute to the development of more accessible treatments on a global scale.
