Complete Response Letters
Scilex Pharmaceuticals, Inc.: ZTlido
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 10, 2016
SCI-LIDO-DERM-001, or conduct a new study to evaluate adhesion using the duration and method of administration for ZTlido that will be proposed for labeling and that administers Lidodoerm according to its package insert.
CRL_NDA207962_20160510:p2:s4To address this deficiency, conduct a new adequately-designed comparative bioavailability study to demonstrate equivalent systemic exposure to Lidoderm patch 5%.
CRL_NDA207962_20160510:p2:s14ZTlido was associated with a higher proportion of subjects with an irritation score of 3 or above (8% versus 0%), and approximately 26% of subjects had a cumulative score greater than or equal to 2 with ZTlido versus 1.8% with Lidoderm.
CRL_NDA207962_20160510:p6:s24Provide a risk-benefit analysis addressing the potential benefits of ZTlido that would offset concerns about the dermal safety profile.
CRL_NDA207962_20160510:p6:s28More Complete Response Letters
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