• Addex Therapeutics SA, of Geneva, reported top-line data showing that a Phase IIa trial testing dipraglurant, a small-molecule allosteric modulator, in Parkinson's disease patients suffering from debilitating levodopa-induced dyskinesia (LID) met its primary endpoint, with the drug exhibiting a good safety and tolerability profile. Dipraglurant also demonstrated a statistically significant reduction in LID severity at both 50-mg and 100-mg doses, and the drug appeared to reduce dystonia severity in addition to chorea.

• iBio Inc., of Newark, Del., completed the first human trial of its H1N1 influenza vaccine (HAC1). Results of the Phase I dose-escalation study showed the vaccine was safe and well tolerated at all dose levels, with or without adjuvant. No serious adverse events or dose-limiting toxicities were reported. The vaccine elicited high levels of immune response correlating with the amount of antigen when the vaccine was not made with adjuvant.

• Noven Pharmaceuticals Inc., of Miami, a wholly owned subsidiary of Hisamitsu Pharmaceutical Co. Inc., of Japan, completed a Phase III program evaluating low-dose mesylate salt of paroxetine (LDMP) for hot flashes of menopause. The two studies enrolled 1,180 subjects from 130 centers in the U.S. In the first study, all primary outcome measures of changes in frequency and severity of hot flashes achieved statistical significance. In the second study, all primary outcome measures were achieved, except for severity at week 12, which did not reach statistical significance.