Elevated Liver Enzymes at Center of FDA Move on Proellex

According to news reports, The Food and Drug Administration, citing elevated liver enzymes at certain dosage levels, has put a hold on trials of a drug called Proellex. The decision was based on the occurrence of high liver enzymes levels with 50mg and 25mg doses, along with input from a panel of experts.The FDA cited safety reasons.

Repros, the company that produces Proellex, had voluntarily decided to suspend dosing of all patients in clinical trials for safety reasons.

Repros and the FDA planning further discussion for September. The discussions will center on the safety of Proellex and the overall direction and scope of the clinical trials.

Depending on the outcome of the discussions, the clinical hold may be lifted and the trials of Proellex be safely resumed.  

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