• Eli Lilly and Co., of Indianapolis, said that its recently completed Phase III (SQUIRE) trial of necitumumb (IMC-11F8) in combination with gemcitabine and cisplatin as first-line treatment for non-small-cell lung cancer (NSCLC) met its primary endpoint of increasing overall survival compared to chemotherapy alone. The trial enrolled 1,093 patients with stage IV metastatic squamous NSCLC. Necitumumab is a fully human IgG1 monoclonal antibody designed to block the ligand binding site of human epidermal growth factor receptor.

• Upsher-Smith Laboratories Inc., of Maple Grove, Minn., reported that USL255 (extended-release topiramate), an investigational once-daily formulation for the management of epilepsy, demonstrated equivalent systemic exposure with an improved topiramate's pharmacokinetic profile at steady-state, as measured by a significantly lower Cmax (p =/< 0.001) and higher Cmin (p =/< 0.001), when compared to immediate-release topiramate (TPM-IR) administered twice daily in healthy volunteers. Additionally, upon switching from TPM-IR, USL255 maintained steady-state topiramate concentrations. Although both study drugs were generally well tolerated in the healthy volunteers, subjects receiving 200 mg/day of USL255 were observed to have fewer side effects related to cognition and memory impairment than those receiving TPM-IR (1/36 for USL255 vs. 3/38, and 0/36 for USL255 vs. 3/38, respectively). The study was published in the August 2013 issue of Epilepsia.