Emmaus product meets in Phase III sickle cell trial

Emmaus Life Sciences Inc. (Torrance, Calif.) said twice-daily oral L-glutamine powder ( Levoglutamide) met the primary endpoint of reducing median frequency of sickle cell crises from baseline to week 48 vs. placebo in a Phase III trial to treat sickle cell disease. L-glutamine reduced median frequency of sickle cell crises by 25% over placebo (p=0.008). L-glutamine also met the secondary endpoint of reducing the median frequency of hospitalizations from baseline to week 48 vs. placebo (reduction of 33% over placebo, p=0.018). The double-blind, U.S. trial enrolled 230 patients ages five and older with two or more documented episodes of sickle cell crisis within 12 months of the screening visit.

Mid-year, Emmaus plans to submit an NDA to FDA for L-glutamine to treat sickle cell disease. Emmaus already markets the product -- a powder formulation of the amino acid L-glutamine for use in an oral solution -- as NutreStore to treat short bowel syndrome. ...