On April 3, 2012, UCB announced that the 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?FDA approved for the treatment of the signs and symptoms of early stage idiopathic PD. A new formulation of Neupro was also approved by the FDA.
Neupro will be available in the US in July 2012.
Analysis:
Neupro is a once-daily dopamine agonist patch that was FDA approved on May 9, 2007. Neupro provides continuous drug delivery for patients with PD and RLS. Neupro is marketed by UCB, Inc. Neupro was withdrawn from the market in 2008 because of problems with the active ingredient crystallizing in the patch. In 2010, the FDA recommended Neupro be reformulated before it could be marketed in the US again.
Using data from AERS, from 01/01/2004 to 9/30/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 1,237 patients who experienced a serious adverse event where Neupro was identified as a suspect drug causing the event and 1,109 patients who experienced a serious adverse event where Neupro was identified as the primary suspect. The most commonly reported side effects were pharmaceutical product complaint, drug ineffective, and application site reaction. We identified 251 hospitalizations and 55 deaths where Neupro was identified as the primary suspect.
