Solorel macimorelin: SPA received

Aeterna Zentaris received an SPA from FDA after amending the protocol for an ongoing, open-label, U.S. Phase III trial evaluating Solorel to diagnose AGHD. The trial, which had enrolled 42 AGHD patients and 10 healthy controls, will enroll an additional 30 healthy controls to be matched with AGHD patients from the original protocol, plus an additional 10 AGHD patients and 10 matched controls. The amendments would bring total enrollment in the trial to about 100. All subjects will receive a single dose of 0.5 mg/kg Solorel. The company reported interim data from the trial last October (see BioCentury, Oct. 11, 2010). ...