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studies; there will be studies spawned by some of the questions that have arisen during the development program in the NDA analysis. Phase-IV studies will be underway and should be planned. Many companies will embark upon seeding programs to enhance the experience of critical prescribers in the field with the product in question. Clearly these studies must be well controlled and well designed. They should also be monitored and they should be contrived in such a way as to produce useful exposure data. This both protects the drug, diminishing the chance for adversity during a critical period of regulatory review, and makes the expenditure of time and effort worthwhile by increasing patient exposure. When this is done in a controlled fashion, even a more serious blip on the curve will usually be ironed out with this being seen in a concomitantly treated population on a control or standard therapy. Uncontrolled exposure really places the drug in considerable jeopardy and every report that builds up on the reviewer's desk is another question, if you look at the data hard enough. The question will arise: was there a trend that has not been revealed so far? This will only slow the drug's evaluation. |
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Another area that needs attention is the development of the product insert. Clearly the entire development program has been aimed at determining the indications, the pharmacokinetics, the preclinical pharmacology, the adverse profile, and the appropriate doses. From the very beginning the product insert has been sketched out, but as the process has progressed, more information has been obtained and this should be a working document that has already been drafted and now is in its final stages. Also during this period, it is time to review the database and see if clues are given to other potential uses of the drug that could then be explored. If one is developing an antiarrhythmic agent and considerable benefit has been seen in the field of ventricular arrhythmias, possibly this is the time to start developing a program around a supraventricular arrhythmia indication. A drug that reduces sudden death mortality in the heart failure population such as what has been reported with vesnarinone, which has type-III antiarrhythmic properties, may need to be at this stage evaluated as an antiarrhythmic agent in other populations (6). Perhaps there are other niches that the drug could be fitted into and other uses explored. To many, this is something that the clinicians do, that is not worth the time and effort of industry. I think this is a very misguided approach. The benefits one can get, the additional information that can be disseminated, and the aid in prescribing guidelines can be helpful to all. If the drug turns out to be adverse in some situations, we then have guidelines and parameters to use to decide when not to use the drug. If it turns out that the drug is beneficial, that is even more reason for its use. There is a certain regulatory rapport that can be developed and confidence that can be built by exploring the scientific aspects of the drug that will help guide the medical community. These are very important considerations and ones that are often overlooked. In the field of antihyper- |
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