24th Nov 2015 11:01
LONDON (Alliance News) - Futura Medical PLC Tuesday that it has been advised by a key European regulator that "in principle" it will not need to undertake further clinical efficacy studies for its topical pain relief products TPR100 and TIB200 ahead of submitting them for approval in Europe.
In July the company announced positive results for both products, showing "statistically significant pain relief" in a clinical study.
Elsewhere the company is also preparing for a formal meeting with the US Food and Drug Administration to establish a regulatory pathway for the two products, although products of this type are only currently available with a doctor's prescription in the US.
"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," said Chief Executive Officer James Barder in a statement.
Shares in Futura were up 5.3% at 24.49 pence Tuesday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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