boost for global diclofenac gel market

Results of a new study by Novartis and Endo researchers into the long term tolerability of diclofenac gel in the treatment of knee OA for the elderly and those with comorbidities have been published this week.(1)

Although previous studies had suggested that diclofenac gel was generally effective and safe for longer term use (2) the product has been sold with warnings for the elderly and pregnant and those with comorbidities such as heart disease, hypertension, stomach ulcers and kidney and liver disease(3, 4)

This latest study of 947 patients over 3, 9 and 12 months concluded that longer term treatment with diclofenac gel is safe in patient subpopulations with an elevated risk of NSAID-related adverse events, such as the elderly and those with the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease.

Osteoarthritis (OA) is the most common form of arthritis, and the World Health Organization estimates that globally 25% of adults aged over 65 yr suffer from pain and disability associated with this disease.(5) This is a considerable number, as the current global population of those aged over 65 years now exceeds half a billion. (6) A large proportion of patients with OA suffer from comorbidities, including hypertension, cardiovascular disease, peripheral vascular disease, congestive heart failure, renal function impairment, diabetes and respiratory disease. One study of 1000 patients undergoing surgery for hip OA found that 90% had comorbid disease or history of comorbid disease.(5)

Thus the option of using diclofenac gel for the longer term treatment of OA has hitherto been limited to a relatively small percentage of sufferers. These new clinical studies by Novartis (and Nuvo) to prove safety and tolerability of longer term use of topical diclofenac, especially in the elderly and those with common comorbid diseases, are obviously intended to dramatically expand the potential global market for topical diclofenac.

I am in no doubt that the strategy will be successful. This development bodes well for POH.

(1) http://www.dovepress.com/long-term-tolerability-of-topical-diclofenac-sodium-1-gel-for-osteoart-peer-reviewed-article-CIA

(2) https://physsportsmed.org/doi/10.3810/psm.2011.09.1918

(3) http://www.voltarengel.com/consumer/default.aspx

(4) http://www.emedicinehealth.com/drug-diclofenac_topical/article_em.htm

(5)http://rheumatology.oxfordjournals.org/content/43/suppl_1/i4.full.pdf

(6)http://www.prb.org/Articles/2011/agingpopulationclocks.aspx