New data has been reported from the open-label extension period of a phase 2 clinical trial of ampreloxetine (TD-9855; Theravance Biopharma, South San Francisco, CA) for the treatment neurogenic orthostatic hypotension (nOH). The data show that treatment with ampreloxetine improved not only symptoms but also activities of daily living.
Of 21 individuals who began the open-label extension period, 16 completed 4 weeks of treatment. Their mean improvement in daily activity after 4 weeks of treatment was 1.1 points on the Orthostatic Hypotension Daily Activity Scale (OHDAS). Mean improvement in symptom severity was 1.0 points as measured by Orthostatic Hypotension Symptom Assessment (OHSA). Treatment with ampreloxetine increased patients' standing systolic blood pressure (SBP) to normal levels at all time points on all weekly clinic visits compared to their low pretreatment baseline, which was sustained throughout the 20 weeks of ampreloxetine therapy.
"The totality of data from this open-label trial are encouraging as the results demonstrate consistent and durable improvements across both symptom severity and daily activity performance for nOH patients following ampreloxetine treatment,” said Horacio Kaufmann, MD, Felicia B. Axelrod professor of dysautonomia research, Department of Neurology, New York University School of Medicine. “While larger, placebo-controlled studies are required to further evaluate the compound's therapeutic impact, the findings from this study offer optimism for the potential of ampreloxetine therapy to address the debilitating affect that nOH has on patients."
Ampreloxetine is an investigational, once-daily oral norepinephrine reuptake inhibitor (NRI) in development for patients with symptomatic nOH. The compound has high affinity for binding to norepinephrine transporters. By blocking the action of these transporters, ampreloxetine causes an increase in extracellular concentrations of norepinephrine.
David Z. Rose, MD
Michelle L. Dougherty, MD, FAES, FAAN
Bettina Balint, MD