UCB medication approved by FDA for Parkinson’s and RLS symptoms

UCB announced today that the U.S. Food and Drug Administration (FDA) approved Neupro® (Rotigotine Transdermal System) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson’s disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome (RLS). Neupro® was previously approved by the FDA for the signs and symptoms of early stage idiopathic PD. Neupro® is a dopamine agonist patch that provides continuous drug delivery for patients with PD and RLS. The FDA has also approved UCB’s new formulation of Neupro®.

"Neupro® represents an innovation in the treatment of Parkinson’s disease and restless legs syndrome," said Prof. Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President of Global Projects and Development at UCB. "UCB is thrilled to make Neupro® available to patients living with these serious diseases."

About Parkinson’s disease

Parkinson’s disease (PD) is a chronic, degenerative neurological disease which affects approximately seven million to 10 million people worldwide. PD develops with the loss of nerve cells in the brain that produce a chemical called dopamine. The symptoms of PD can have an impact on many dimensions of patients’ lives. As dopamine levels fall, movement (motor) symptoms—tremors (uncontrollable shaking), rigidity (stiffness or muscle tensing) and bradykinesia (slowness and loss of spontaneous movement)—can progress, along with the underlying symptoms of PD, which are less well recognized and may be under-treated. Underlying symptoms can occur in over 90% of PD patients and include sleep disturbance, such as insomnia, vivid dreams and daytime drowsiness, mood and cognitive changes, pain, depression, anxiety, apathy, gastrointestinal disorders, sexual dysfunction, bladder problems and fatigue.

About Restless Legs Syndrome

Restless Legs Syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and an uncontrollable urge to move to gain relief. Over 80% of people with RLS also have periodic limb movement disorder (PLMD), which causes rhythmic limb movements during sleep. RLS affects between three percent and 10 percent of the U.S. population to some extent. Some estimates are much higher because RLS is thought to be underdiagnosed, and in some cases, misdiagnosed. Most people with RLS have difficulty falling asleep and staying asleep. Daytime symptoms of RLS, such as inability to sit still and involuntary leg jerks, are increasingly recognized. While the underlying pathophysiology of RLS is not fully understood, it is thought to involve central dopamine systems. Recent neuroimaging data suggest that RLS patients may carry an abnormality in dopamine transport that can be visualized both day and night. RLS can cause exhaustion and daytime fatigue, and may affect work and personal relationships. Patients with moderate-to-severe RLS are often unable to concentrate, have impaired memory, or fail to accomplish daily tasks. These patients may require long-term treatment for their RLS symptoms.

Neupro® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.

The most common adverse reactions (≥5% greater than placebo) for the highest recommended doses of Neupro® for treatment of Parkinson’s disease are nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, hyperhidrosis, and insomnia. The most common adverse reactions (≥5% greater than placebo) for the highest recommended dose of Neupro® for treatment of Restless Legs Syndrome are application site reactions, nausea, somnolence, and headache.