Futura Medical gets FDA OK for confirmatory study of erectile dysfunction gel
Futura Medical shares surged on Monday after the company said it had agreed with the US Food and Drug Administration on the protocol for a small confirmatory clinical study of its erectile dysfunction gel, MED3000.
The pharmaceutical company said the clinical study - FM71 - will be conducted prior to formal regulatory submission as a DeNovo Medical Device. Detailed planning for the commencement of the study has now begun and first patient dosing is expected in the second half of this year.
FM71 is designed to provide supplementary efficacy data to the previously reported FM57 study with a "least burdensome" approach and modest cost, Futura said. While the overall design is similar to that of the previous large phase study that recruited about 1000 patients, no placebo cohort is required, hence the study is relatively smaller in size with approximately 100 patients.
The previous study lasted three months, whereas the new one will last six "to reassure the FDA that the efficacy does not diminish over a longer period of time", Futura said.
The company also confirmed on Monday that the co-ordinating principal investigator will be Professor Arthur Burnett, who is Professor of Urology at Johns Hopkins School of Medicine.
Burnett said: "In my humble opinion and as an expert in the field of erectile dysfunction management, I am very supportive of MED3000 and do believe that it offers an important and valid addition to the armamentarium of treatments we can offer our patients for erectile dysfunction. I am very pleased to support Futura Medical in the further clinical investigation of this novel topical treatment."
At 1050 GMT, the shares were up 68% at 77.25p.
House broker Liberum said: "The US opportunity is worth at least twice that of the European opportunity where Futura received confirmation of approval (due by the end of May) last Friday. Today’s announcement removes the uncertainty around the clinical trial structure for the US and adds to the significant momentum at Futura."