Chelsea Given UK Thumbs Up to Begin Fibromyalgia

The UK’s Medicines and Healthcare products Regulatory Agency granted approval to Chelsea Therapeutics to begin a Phase II trial of Droxidopa, alone and combined with carbidopa, for the treatment of fibromyalgia.

Norepinephrine (NE) is a neurotransmitter in the central and peripheral nervous systems that has been linked to both chronic pain and depression. Droxidopa is a synthetic amino acid that the body converts into NE to provide replacement therapy for NE deficiency, according to the company.

The company plans to initiate the multicenter, randomized, double-blind, placebo-controlled, dose-response trial in September.