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Futura Medical trial of erectile dysfunction drug gets FDA nod, eyes first dosing in H2
StockMarketWire.com
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Pharmaceutical company Futura Medical said its phase 3 clinical trial for its erectile dysfunction treatment would get underway in the second half of the year after the US Food and Drug Administration signed off on the company's plans for the clinical study.
The company received official minutes from the US Food and Drug Administration for MED3000. The minutes signify an agreement between the FDA and Futura on the detailed clinical study design for the small confirmatory clinical study, FM71, to be conducted prior to formal regulatory submission as a DeNovo Medical Device. Detailed planning for the commencement of FM71 had now begun with first patient dosing expected H2 2021, the company said. Two co-primary endpoints would measure the significant clinically meaningful effect as calculated using the Rosen and Araujo statistical method -- a standard assessment technique for measuring patient reported outcomes. 'Whilst the overall design is similar to that of the previous large phase 3 FM57 study that recruited approximately 1000 patients, no placebo (sham) cohort is required, hence the study is relatively smaller in size with approximately 100 patients,' it added. At 8:19am: (LON:FUM) Futura Medical PLC share price was 0p at 14.75p
Story provided by StockMarketWire.com
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