Futura Medical, a transdermal technology specialist, has received by an European regulator clarity on the regulatory pathways for its two topical pain relief products, TPR100 (diclofenac) and TIB200 (ibuprofen).
The company on Tuesday pointed out that it has been advised by “a key European regulator” that the company has had a meeting with, 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.
According to Futura, 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 says it expects to use Europe’s decentralized regulatory process to gain Marketing Authorizations in all key EU markets. The over the counter (OTC) topical pain relief market in the top five EU countries was worth over $750 million in 2014, the company notes.
Futura added it was 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. Futura noted that the topical NSAID market in the USA, where a prescription is required, was worth $625 million in 2014.
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.”