boost for global diclofenac gel market, page-10

A couple of quick points.

Im a believer in the superior risks / benefits of topical NSAIDS compared to the oral version. But this doesn’t alter the fact that in December 2009 the FDA issued a safety warning for Voltaren gel for Liver damage and that warning is still current.

Which I assumed was what POH was alluding to when they referred to safety concerns expressed by the FDA and which then featured in their decision not pursue this further at the time.

Adverse effects from NSAIDS are dose related. The advantage of the gel (which is well absorbed through the skin) puts the medication exactly where you need it and so less is needed. Voltaren gel at 1% has systemic absorption of 94% less than the oral treatment.

Therefore much less in the bloodstream so less risk (but not nil risk) of all the nasty cardiovascular thrombotic events, myocardial infarction, strokes. But because of possible liver damage the daily dosage shouldn’t exceed 32 grams and it should only be used with the lowest effective dose for the shortest duration possible. Also on the downside you get adverse site reactions – 7% of patients.

So while Voltaren gel has a good risk benefit profile what is the argument for the TPM powered version. Is it that you can somehow achieve the same efficacy with less dose making it safer? Or less dose for the same results makes its cheaper to produce? Or that it might reduce skin reactions because less might be needed?

If you want more absorption just rub more on – or buy the higher strength stuff over the internet from Europe. I find it difficult to accept without some evidence that a TMP gel somehow bends the risk benefit curve. But I suppose we will see what the marketing claim is when the product starts to be sold in India.