Targeting a large potential market with unmet medical need
1 2015 IMS Health Estimate
2 2015 IMS Data source
Topical NSAIDS treatments are recommended by the National Institute for Health and Care Excellence (NICE) as the first line treatment for joint pain associated with osteoarthritis, in preference to oral NSAIDs, owing to concerns over systemic side effects caused by the long term use of oral NSAIDs.
In Europe Futura has partnered with Thornton & Ross, a STADA AG subsidiary, for the manufacturing and distribution of TPR100 in the UK. A marketing authorisation filing was submitted by Thornton and Ross in July 2018 and await responses and action from the UK regulator. Licensing discussions for further regions are ongoing with out-licensee interest pending UK regulatory approval.
In the USA, a Pre-IND response was given by the FDA highlighting the path for regulatory approval with a simplified new drug application 505(b)(2) filing route. FDA requires a 700 patient, placebo controlled 12-week efficacy study. Futura made the strategic decision to require partner commitment before progressing this clinical expenditure.