The design of clinical protocols has to be right to succeed. The protocol to support Tylenol-PM, as described in FDA's letter to the CHPA [http://fdcalerts.typepad.com/files/100419_fda_sleep-aid_analgesic_rejection.pdf], suggests that the clinical protocol was doomed from the start. Any new attempt must invest in the right vehicle.
Our previous comments on the lack of support for Tylenol-PM (J&J) efficacy was based on experience, not having read FDA's letter to CHPA. Having now read the letter our comments were well taken and there is now reason to further believe it was a doomed endeavor. As I see it, as one who has managed over 150 clinical trials of OTC products, several design features were ill advised. To be fair we have not reviewed the protocol itself.
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