boost for global diclofenac gel market, page-5

Hottod – good find but post hoc analysis, sub-samples too small and no comparator group. Hence why the paper is published in Dove Press (vanity publishing).

As I understand it POH abandoned its push on diclofenac in 2010 after its successful 1b trials in 2009 citing FDA safety concerns. Since this time those safety concerns do not appear to have abated.

Obviously the drug approval process in India is not as rigorous as in the US so its a very interesting move to say the least.

In November last year Poh announced:
This licensing deal is an exclusive one for the Indian market with Themis Medicare obligated to launch the over the counter TPM/diclofenac product within 12 months.

This has now slipped to the 1st quarter 2013 – perhaps due to problems with Themis – or perhaps the approval process?

If you can get more of the stuff through the skin and improve efficacy without increasing risk then this would be pretty impressive and theoretically worth a lot of money. I suspect though that the only thing that would convince the FDA of this would be some large expensive trials - exactly the problem as it was in 2009.