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FDA Approves d4T Once Daily, Extended Release Formulation
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Today the Food and Drug Administration approved a new, extended release
formulation of ZERIT (stavudine , d4T) called ZERIT XR. This
extended-release formulation has been demonstrated to maintain measurable
plasma concentrations for 24 hours after once-daily dosing. ZERIT XR is
indicated for the treatment of HIV in combination with other
antiretrovirals. The recommended dose of ZERIT XR is 100 mg once daily for
individuals weighing at least 60 kg and 75 mg once daily for individuals
weighing less than 60 kg.
In a clinical study conducted in 783 treatment-naive, HIV-infected
individuals ZERIT XR was comparable to the previously approved twice daily
formulation of ZERIT. In this randomized, controlled study, participants
were randomized to either the extended release or standard formulation, in
combination with lamivudine and efavirenz. The proportion of patients with
HIV-RNA (viral load levels) below 400 copies/mL at 48 weeks was 79% and 76%
for the extended release and immediate release-containing regimens,
respectively. For viral load under 50, the response rates were 55% and 57%
for the new and old formulations, respectively. The tolerability and safety
profile of the new once daily, extended release formulation is comparable to
that of the previously approved twice daily formulation.
The study results were supported by a second, smaller study in 150 treatment
naive patients.
More convenient formulations, such as ZERIT XR, may help patients with HIV
more readily adhere to treatment regimens.
The full label will soon be available at the FDA website at
http://www.fda.gov/cder/approval/index.htm Simply click "Z" in the index,
and scroll to look for ZERIT XR.
ZERIT XR is a product of the Bristol-Myers Squibb Company.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
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