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Futura Medical PLC on Wednesday said its erectile dysfunction drug candidate MED3000 showed positive data from a phase 3 study.
The Guildford, England-based pharmaceutical company explained that after 24 weeks of treatment, patients showed ‘a statistically significant improvement in erectile function compared to baseline’. It added that safety and tolerability data were also ‘highly positive’, citing no serious adverse events.
In a questionnaire, 85% of patients confirmed that ‘rapid onset of action’ was possible after the 24 week period.
The firm aims to file a dossier with the US's Food & Drug Administration by the end of September and aims to receive authorisation in the US in the first quarter of 2023. It emphasises that authorisation would be the ‘first major erectile dysfunction treatment available over the counter throughout the US’.
Futura Medical shares were 14% higher at 42.21 pence each in London on Wednesday morning. The stock is up 5.5% in the past 12 months.
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