The company has learned that OGD has recommended a bioequivalence study characterizing the pharmacokinetic profile of lidocaine as well as a skin irritation/sensitization study of any lidocaine-containing patch formulation.
This deviates from Endo's understanding of the applicable regulations and of OGD's past practices, which, for a topically acting product, have generally required demonstration of bioequivalence through a comparative clinical efficacy study.
Lidoderm® is a topically acting product that works locally at the site of application rather than through systemic absorption of the active ingredient.
While Endo believes that clinical studies consistent with those required for other topical products are more appropriate in proving bioequivalence to Lidoderm and has already expressed this view to OGD, discussions are currently ongoing.
Lidoderm (lidocaine patch 5%), a topical analgesic patch has been approved by the USFDA in 1999 for the treatment of pain associated with post-herpetic neuralgia (PHN), a chronic condition resulting from nerve damage caused by shingles.
Lidoderm produces an analgesic effect by the penetration of lidocaine and should only be applied to intact skin.
Find more details about the issue at the press release.
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