Poor Dutch drugmaker Organon. They have terminated the LIFT study of its hormone replacement therapy Livial after an interim analysis showed that the agent increased the incidence of stroke.
LIFT was designed to investigate the effect of tibolone on new vertebral fractures in elderly osteoporosis patients.
But last October, a report on the side effect ran in the British Medical Journal.
At the time, Organon decided to continue the trial until the next analysis point in January 2006 to see if the problem persisted.
Organon had hoped that approval in osteoporosis would give Livial a much needed lift - but no, it was not to be.
The product has seen its sales decline in the face of the general downturn in the HRT market that has occurred since the release of the Women's Health Initiative study results, which revealed that HRT was associated with an increase in cardiovascular risk.
Sales of Livial in 2005 fell 6% to $195m.
Source: PharmaTimes
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