• AcelRx Pharmaceuticals Inc., of Redwood City, Calif., said it started a Phase II trial of ARX-02, a sublingual sufentanil NanoTab product candidate for cancer breakthrough pain control. The primary objective of the study is assessment of safety, tolerability and efficacy of the drug relative to placebo in cancer patients experiencing episodic breakthrough pain. ARX-02 is a small tablet formulation of sufentanil designed to allow for the rapid uptake of the opioid following placement under the tongue to minimize transmucosal drug uptake and limiting the proportion of swallowed drug.

• Topica Pharmaceuticals, of Palo Alto, Calif., said it started enrolling patients in a Phase II trial of luliconazole, a broad-spectrum imidiazole product, in tinea pedis (athlete's foot). The study is expected to involve about 120 patients and will test luliconazole cream administered once daily for 14 or 28 days. The primary efficacy endpoint is to achieve complete clearance of the infection at two weeks post-treatment. Topica expects to finish the study by the end of this year, with plans to start a pivotal program in 2010.

• Tranzyme Pharma Inc., of Research Triangle Park, N.C., said its selective ghrelin agonist TZP-101 demonstrated safety and effectiveness in improving multiple symptoms associated with gastroparesis in a Phase II trial. The study enrolled 76 patients with either Type I or Type II diabetes mellitus and a confirmed diagnosis of gastroparesis, randomized to receive a daily 30-min I.V. infusion of one of six doses of TZP-101 or placebo for four consecutive days. Results showed that 80 mcg/kg was determined to be the dose that achieved maximum clinical benefit. Upon completion of the dosing period, improvement in symptoms in TZP-101-treated subjects was statistically significant (or trending toward significance) over placebo-treated patients as determined by at least one of the three gastroparesis measures used in the trial to measure symptoms, including vomiting, loss of appetite, postprandial fullness, early satiety, abdominal distension and bloating.