Theravance has begun a Phase II study with TD-9855, an investigational norepinephrine and serotonin reuptake inhibitor (NSRI), for the treatment of fibromyalgia.
TD-9855, the lead compound in Theravance’s monoamine reuptake inhibitor programme, was discovered for the treatment of central nervous system (CNS) conditions such as chronic pain and Attention Deficit Hyperactivity Disorder (ADHD).
Theravance research and early clinical development senior vice president Dr Mathai Mammen said there is considerable opportunity for therapies with a reasonable 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 said.
The Phase II proof-of-concept study will randomise around 375 fibromyalgia patients with TD-9855 or placebo, once-daily for up to nine weeks, and assess the safety and efficacy of two TD-9855 doses.
Improvement in pain is the primary endpoint of the study, while additional secondary or exploratory endpoints include improvement in other established fibromyalgia measures and impact on important comorbidities, such as fatigue.
Besides the Phase II fibromyalgia study, the company is evaluating TD-9855 in an ongoing Phase II safety and efficacy study in adults with ADHD.
The monoamine reuptake inhibitor programme is focused on developing a monoamine reuptake inhibitor for the treatment of diverse CNS conditions such as chronic pain, ADHD and potentially depressive disorders.