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Sertraline + CBT – a new 505(b)(2) Combo

Several news sources report today (10/31/2008) that a new study shows that sertraline in combination with CBT eases anxiety in children.  A number of 505(b)(2) development projects arise from observing these kinds of trials:  an efficacy study shows that two (or more) concurrent treatments are safe and effective for a given set of indications.  It would seem that a sponsor could just put the two drugs into the same dosage form and get it approved.  True, and FDA has regulations and guidance just for this situation.  One thing that must be studied is the potential for the two drugs to interact.  Another need is to show the contribution of each drug to the treatment.  These requirements make combination drugs more expensive and time consuming than single-entity drugs.  Thus, the economic proposition must be considered:  yes, the combined dosage form is more convenient than taking two drugs, but if the two existing products are generic, will the market pay for this convenience?  Normally, you must do more than just put the drugs together – dose and schedule may be altered, for instance.

In the subject case, the study was government funded, likely because the products are generic.  The major development hurdle here, if a sponsor wanted to combine sertraline with CBT, is the dosage form.  CBT is cognitive behavior therapy (talk therapy).

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