FDA asks UCB to solve Neupro formulation

Due to formulation problems, the US Food and Drug Administration has rejected Belgian drugmaker UCB's Neupro (rotigotine transdermal system),  a skin patch for the signs and symptoms of advanced Parkinson's disease  and moderate-to-severe primary restless legs syndrome.

In its complete response letter, the FDA concluded that there was  substantial evidence of effectiveness for Neupro in both indication, but  noted that the firm needs to first resolve the issue of crystal  formation in the patches. UCB will discuss the contents of the CR letter  and the next steps with the FDA soon.

UCB recalled all batches of Neupro from the US market, as well as  certain consignments to Europe, after reports of reduced efficacy  (Marketletter March 31, 2008). In Europe, a complete cold-chain storage  and distribution system was implemented by September 2008 to control  the crystal formation issue and allowed existing patients to continue  their therapy, the firm noted.