A further update on MED3000’s EU regulatory approval will be made alongside its interim results in September and the target remains a 2021 approval date, it added.
In the US, Futura said that after a second pre-submission meeting with the US Food and Drug Administration (FDA), a pathway to US marketing approval for MED3000 has been established.
Importantly, this will be without the need for a doctor’s prescription, Futura added, so MED3000 will be sold over-the-counter alongside other leading treatments for erectile dysfunction such as Viagra and Cialis, which are also sold without prescription.
The FDA also indicated a requirement for certain additional clinical efficacy data beyond the company’s three months’ home use study conducted in 2019 in 1,000 patients suffering from mild, moderate and severe ED (“FM57”).
This additional data will require a further small clinical trial, said Futura, where patients with erectile problems will receive MED3000 for a six-month treatment period.
“Confirmatory studies such as this generally require low subject numbers and is likely to be significantly smaller in size than FM57,” said Futura.
Next steps will be to confirm design of the new clinical trial with the FDA to provide the necessary reassurance of MED3000’s efficacy for up to six months, it added, and progress the OTC label and leaflet development.
James Barder, Chief Executive of Futura Medical commented: “Futura is executing and delivering against strategic plans. We are pleased to have now submitted MED3000 for European approval as a clinically proven treatment for ED.
“Once granted, EU approval will allow MED3000 to be marketed throughout the EU without the need of a doctor’s prescription subject to any national marketing restrictions. This represents a significant commercial opportunity.”
Published at Tue, 14 Jul 2020 07:04:00 +0000-Futura Medical submits MED3000 for European approval, US wants new confirmatory trial