DuPont Pharmaceuticals has submitted a New Drug Application to the USFood and Drug Administration for 600mg and 300mg tablet formulations of its anti-HIV drug, Sustiva (efavirenz), as a once-daily non-nucleoside reverse transcriptase inhibitor.
The firm notes that the new form may help patients better adhere to their anti-HIV treatment as only one tablet per day is required, compared to three capsules a day for the current formulation of the drug. Studies comparing directly-observed therapy to self-administered therapy showed that the latter, with a regimen containing Sustiva plus NRTIs, was almost as effective. DuPont hopes to launch the new formulations in early 2002, but will continue to manufacture the existing 200mg immediate-release capsules for those who prefer them.
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