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# Futura to Seek FDA Placebo Pathway for ED
- URL: https://www.fdaweb.com/futura-to-seek-fda-placebo-pathway-for-ed/
- Published: 2019-12-12T12:00:00.000Z
- Updated: 2026-09-14T15:56:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145707

Futura Medical says it intends to pitch to FDA a medical device regulatory approval pathway for the placebo arm from the European erectile dysfunction (ED) Phase 3 study FM57 after the placebo arm outperformed the active study drug, MED2005 (nitroglycerine) gel. The placebo gel contained the company’s proprietary transdermal DermaSys drug delivery technology, and it “demonstrated statistically significant and clinically meaningful top-line results, meaning that FM57 did not meet primary endpoints versus placebo,” the company says. “While this placebo does not contain the active pharmaceutical ingredient, nitroglycerin, used in MED2005, it uses the key ingredients that constitute DermaSys’ proven transdermal technology and was shown to be as effective in the treatment of ED as the active doses.”

Futura Medical says that it intends discuss potential next steps with FDA to move the placebo through a “new simpler and expected lower cost regulatory pathway. Although FM57 has not met the primary endpoints versus placebo, we believe the data demonstrating that DermaSys formulation alone achieved statistical significance compared with baseline for all the primary and key secondary endpoints is an interesting outcome that may enable an alternative pathway to regulatory approval.”