Elan cuts high doses in drugs trial
While the Dublin and Athlone-based pharmaceutical company — best known for its multiple sclerosis drug Tysabri — took the decision to modify the trials, along with the Independent Safety Monitoring Committee (ISMC), it said “a direct relationship” between the drug, code-named ELN D005, and the deaths “has not been established”.
While it is uncertain as to what role the testing had in the deaths, it was felt that the highest doses — 2,000mg and 1,000mg both twice daily — showed a generally lower level of tolerability amongst patients. According to Elan, no concerns have been recognised in the test treatment of patients using the lower dose of 250mg twice daily. In all, 353 patients have been taking part in the latest trials, which will continue at the lower dosage level.