SkyePharma and CTI submit reformulated zileuton to FDA

UK-based drugmaker SkyePharma says that its US partner Critical Therapeutics has completed the submission of a New Drug Application to the US Food and Drug Administration in relation to its oral anti-inflammatory drug zileuton, which is a new formulation of CTI's currently-marketed asthma treatment Zyflo. The new version of the drug is designed to be taken twice-daily, rather than four times a day like Zyflo.

Originally marketed as Zyflo Filmtab by US health care major Abbott Laboratories, the drug was obtained by CTI in 2003 and has since been developed in collaboration with SkyePharma. The UK firm is entitled to a single-digit royalty payment based on sales of products which utilize the new formulation.