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Imprimis to delay phase 3 topical NSAID trial for Impracor
Imprimis Pharmaceuticals recently announced a probable delay in its phase 3 topical nonsteroidal anti-inflammatory drug trial for Impracor.
The San Diego-based company said in a press release that it was notified by DPT Laboratories, its contract manufacturing supplier, that a placebo formulation batch had failed, and an active batch of Impracor “showed a lower than expected specification result.”
Impracor is based on a combination of Imprimis’ Accudel cream and 10% ketoprofen to be applied directly to the injury site. Topical ketoprofen is used widely in Europe, while it is available orally, but not topically in the United States, according to Imprimis.
Imprimis is waiting to review the complete chemistry, manufacturing and controls report before proceeding, according to the release.
“We believe that this unexpected delay will not materially affect our ability to execute our business plan, although we do not expect to initiate our phase 3 clinical trial for Impracor during the third quarter of 2013, as we have previously reported,” Mark L. Baum, Imprimis CEO, said in the release.