Macrilen: Ph III data

Top-line data from about 110 patients with suspected AGHD and healthy volunteers in an open-label, 2-way crossover, international Phase III trial showed that a single oral dose of 0.5 mg/kg Macrilen missed the primary endpoint of achieving equivalence to an insulin tolerance test in diagnosing AGHD. Aeterna Zentaris said the estimated percent negative diagnostic agreement met the trial’s success criteria, but the estimated percent positive diagnostic agreement did not. In 2014, FDA issued a complete response letter for Macrilen (see BioCentury, Nov. 24, 2014)...