Hepatitis Pharmaceutical Drugs Development Halted Due to Side Effects
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Pharmaceutical Drugs News - Shares of Idenix Pharmaceuticals took a tumble this week, after regulators decided to halt the further development of its two new medications, due to side effects discovered during clinical trials.
The FDA made the decision after three cases of liver side effects were reported, after patients had taken IDX 184 and IDX 120, two experimental prescription drugs. The reported liver effects were not serious, however, and volunteer patients regained normal liver function after ceasing the medication.
Prescription Drugs Description – IDX 184 & IDX 320
Both IDX 184 and IDX 320 are being developed to treat Hepatitis C, a viral infection spread through skin-to-skin contact and contaminated blood, causing liver damage. The CDC estimates over 4 million Americans to be currently infected wit the Hepatitis C strain.
IDX 184 is an oral pharmaceutical drugs which aims to maximize efficiency, and is currently in mid-stage trials, while IDX 320, designed to prevent viral replication, is in its early stages. IDX 184 is expected to gain approval before next year.
Meanwhile, Idenix’s competitor, Vertex Pharmaceuticals, has seen its stocks rise 238%, as its pharmaceutical drug telaprevir proved effective in clinical trials. In a study entitled REALIZE, 65% of patients found Hepatitis C levels reduced to an undetectable level.
Reported Side effects include itching, rashes, fatigue, nausea, anemia and flu-like symptoms.
Vertex’s partner Tibotec has international commercial distribution rights to pharmaceutical drugs telaprevir internationally - the company is expected to file for regulatory approval in the U.S. before the end of the year.
