Proellex telapristone acetate: Clinical hold ongoing

Repros said FDA confirmed it will maintain its partial clinical hold on oral Proellex telapristone acetate while the agency consults with internal liver experts. FDA placed a full hold on the oral Proellex program in 2009 after clinically significant increases in liver enzymes were observed at doses of 25 and 50 mg in Phase III trials (see BioCentury, Aug. 10, 2009). The agency subsequently converted the full hold to a partial hold in 2010 to allow Repros to conduct a Phase II trial of ≤12 mg Proellex, and again in 2012 to allow Repros to conduct additional trials of low-dose Proellex (see BioCentury, Aug. 10, 2009 & Oct. 15, 2012).

Last November, Repros reported that Proellex met the primary endpoint of reducing excessive menstrual bleeding vs. placebo in a Phase II trial to treat uterine fibroids...