“We are very encouraged about the publication in such a well-known scientific journal. We have already demonstrated statistically significant and clinically relevant efficacy with pudanfensine in ED-related endpoints in a multi-centre phase IIb study, and this publication is another scientific validation of the mechanism of action and strengthens our believe in pudafensine as a novel treatment for patients who do not respond to or do not tolerate the currently marketed drugs,” said
The publication in the
”The scientific work underlying the discoveries is a result of strong collaborative effort, and the publication in the
Pudafensine (formerly IP2015) is in clinical development for both organic erectile dysfunction and neuropathic pain. Within the indication of erectile dysfunction, pudafensine has showed positive results in patients with erectile dysfunction in a phase IIa study, and demonstrated statistically significant and clinically relevant efficacy in ED-related endpoints, with no observations of critical adverse events, in a multi-centre phase IIb study conducted by
Erectile dysfunction is expected to affect 320 million men in 2025. The standard of care is treatment with PDE5 inhibitors, but the treatment is insufficient in 40 percent of the patients. Currently, there is no oral medication for the treatment of patients with erectile dysfunction who have insufficient effects or cannot tolerate PDE5 inhibitors (Munk et al., 2019).
References
https://bpspubs.onlinelibrary.wiley.com/toc/14765381/0/0
Comerma-Steffensen S, Kun A,
Munk NE, Knudsen J, Comerma-Steffensen S, Simonsen U. Systematic review of oral combination therapy for erectile dysfunction when phosphodiesterase type 5 inhibitor monotherapy fails. Sex Med Rev. 2019 Jan 30. pii: S2050-0521(18)30144-6. doi: 10.1016/j.sxmr.2018.11.007.
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