Positive Regulatory Update on Pain Portfolio
24 November 2015
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, announces that, following a positive meeting with a key European regulator, the Company has received clarity on the regulatory pathways for its topical pain relief products, TPR100 (diclofenac) and TIB200 (ibuprofen). Most significantly, Futura has been advised by the regulator that in principle no further clinical efficacy studies are expected to be required for either of the products prior to the submission of regulatory dossiers in Europe.
The two products are based on non-steroidal anti-inflammatory drugs (NSAIDs) and benefit from Futura's transdermal delivery system, DermaSys®, which offers enhanced drug permeation through the skin. TPR100 uses the NSAID diclofenac and TIB200 uses the NSAID ibuprofen. In July this year, Futura announced positive results for the two products, which both showed statistically significant pain relief in a pivotal clinical study.
Futura has been developing the positioning and packaging of the products using the strapline, "DermaSys®: Get to the Point with Pain™". Prototype product packs can be viewed at this link:
It is expected that Futura will utilise Europe's decentralised regulatory process to gain Marketing Authorisations in all key EU markets. The over the counter (OTC) topical pain relief market in the top five EU countries was worth over US$750 million in 20141.
The Company is also preparing for a formal meeting with the FDA to establish the US regulatory pathway for the two products, although topical NSAIDs are only currently available with a doctor's prescription in the USA. The topical NSAID market in the USA, where a prescription is required, is was worth US$625 million in 20141.
James Barder, Futura's Chief Executive, commented: "We are very pleased to have received such encouraging guidance on the regulatory pathway in Europe for these two novel, DermaSys®-based pain relief products. We can now focus on the preparation of our regulatory submissions in Europe and on the regulatory pathway for these innovative products in the USA."
1. Source: IMS data
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Notes to editors:
Futura Medical plc
Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.