Theravance begins TD-9855 Phase 2 study in fibromyalgia patients

The proof-of-concept study will randomize around 375 fibromyalgia patients with TD-9855 or placebo, once a day for nine weeks, and evaluate the safety and efficacy of two TD-9855 doses.

Theravance research and early clinical development senior vice president Mathai Mammen said there is a considerable opportunity for therapies with tolerability profile that manage both fibromyalgia and commonly experienced comorbid symptoms.

"We believe TD-9855’s balance of inhibition of norepinephrine and serotonin reuptake may provide a compelling and differentiated profile versus current alternatives," Mammen added.

Improvement in pain is the primary endpoint of the fibromyalgia study.

Study will also evaluate improvement in other standard fibromyalgia measures and impact on important comorbidities, which consitute the additional secondary or exploratory endpoints.