Theravance Biopharma Launches Physician Education Campaign for Rare Neurological Disorder

Theravance Biopharma has initiated a comprehensive physician education campaign focused on neurogenic orthostatic hypotension (nOH) associated with multiple system atrophy (MSA), a rare and progressive brain disorder. The campaign, titled "Power in the Periphery," comes as the company prepares for the release of pivotal phase 3 data for its investigational drug ampreloxetine.

Campaign Launch and Disease Overview

Theravance unveiled its "Power in the Periphery" campaign at the International Congress of Parkinson's Disease and Movement Disorders, accompanied by the launch of an educational website. The initiative aims to raise awareness about nOH in MSA patients, a condition affecting 70% to 90% of the estimated 50,000 MSA patients in the United States.

nOH is characterized by a sudden drop in blood pressure upon standing, leading to symptoms such as lightheadedness, fainting, and fatigue. The campaign's name reflects the understanding that while MSA primarily impacts the central nervous system, peripheral nerves remain functional and continue to produce norepinephrine, a key neurotransmitter in blood pressure regulation.

Strategic Preparations for Ampreloxetine

The education campaign is part of Theravance's broader strategy to prepare for the potential launch of ampreloxetine, a selective norepinephrine reuptake inhibitor designed to improve standing blood pressure and reduce nOH symptoms. The company has been laying groundwork through various initiatives:

1. A survey of 200 neurologists and cardiologists conducted in late 2024 to assess market readiness.
2. Ongoing disease state education and targeted stakeholder engagement.
3. Discussions with payers to establish the value proposition of the treatment.

Theravance completed enrollment in the open-label portion of a phase 3 trial for ampreloxetine in August 2025, with data expected in the first quarter of 2026. This trial focuses specifically on nOH in MSA patients, following a previous phase 3 study in a broader nOH population that missed its primary endpoint but showed promise in a prespecified MSA subgroup.

Clinical Development and Regulatory Strategy

The company's approach to ampreloxetine's development has evolved based on clinical findings. After the initial phase 3 trial in a diverse nOH patient population failed to meet its primary endpoint, Theravance identified a potential efficacy signal in MSA patients. This led to the current, more targeted phase 3 study.

If the upcoming trial data prove positive, Theravance plans to seek FDA approval for ampreloxetine in the treatment of nOH associated with MSA. The focused development strategy and comprehensive physician education campaign underscore the company's commitment to addressing this rare but significant neurological condition.