131 - I have a question about the permissibility of the phrase "treatment-free" within the following context. If we are promoting a type of treatment with product X, where the patient takes product X for 2 weeks and then does not have to take the medication again until 50 weeks later (i.e. the following year), would we be allowed to say that the patient was treatment-free for those 50 weeks. Product X has a short half-life and is out of the patient's system within 24 hours so the patient would not be receiving treatment for those 50 weeks. Other treatments for the same disease are weekly or monthly, thus discussing the "treatment-free" portion of the treatment regimen is a point we would like to discuss with HCP and patients.
-
The product's TMA will need to be considered to answer this question. It would appear that the patient is still being "treated" even between dosing periods. Also note that some drugs are cleared from the blood quickly (i.e. short half-life) yet the treatment effect lasts a very long time (e.g. some drugs remain bound to the receptor at the active site for a long time). It appears that "dose-free period" may convey your desired message in an acceptable manner. Please call me at the PAAB office such that I can consider this specific case.