Theravance Biopharma is stepping up efforts to educate physicians about a rare disease, launching its “Power in the Periphery” campaign in the run-up to publication of phase 3 data in the indication.
The awareness campaign is focused on the drivers and symptoms of neurogenic orthostatic hypotension (nOH) associated with multiple system atrophy (MSA), a progressive brain disorder. According to Theravance, 70% to 90% of the 50,000 MSA patients in the U.S. have symptoms of nOH, a condition defined by drops in blood pressure after standing, which can lead to lightheadedness, fainting and fatigue.
The company used the International Congress of Parkinson’s Disease and Movement Disorders this month to launch its healthcare professional-focused nOH awareness campaign, which also features an accompanying website.
The campaign name, “Power in the Periphery,” reflects evidence that MSA mainly affects the central nervous system, while peripheral nerves remain functional and continue producing the neurotransmitter norepinephrine.
The website includes text and graphics about different drivers of nOH, explaining that the form of the condition seen in MSA patients is caused by central nervous degeneration. Another section of the website describes how norepinephrine prevents dizziness and fainting.
The campaign is the latest in a series of actions by Theravance to lay the groundwork for its ampreloxetine. The molecule is designed to selectively inhibit norepinephrine reuptake, thereby improving standing blood pressure and reducing nOH symptoms.
For one, the company surveyed 200 neurologists and cardiologists late last year as part of its launch preparation efforts. More recently, management discussed disease state education, targeted stakeholder engagement and talks with payers on an earnings call in May and provided an update on the activities in August.
Theravance is educating physicians and payers in anticipation of phase 3 data on ampreloxetine in nOH due to MSA. The company completed enrollment in the open-label portion of a phase 3 trial in August, putting it on track to report data in the first quarter of 2026. Theravance plans to seek FDA approval if the data are positive.
The company began the study in patients with MSA and nOH after a phase 3 trial in a broader population missed its primary endpoint. Theravance initially tested ampreloxetine in patients with nOH linked to a range of conditions, including Parkinson's disease. While that phase 3 trial missed its primary endpoint, the company identified an efficacy signal in a prespecified subgroup of MSA patients.