As the world’s population reaches an increasing average age and is increasingly affected by welfare diseases such as diabetes and obesity, a problematic side effect for the male part of the population also arises to a greater extent – erectile dysfunction. Erectile dysfunction, impotence in everyday speech, is defined as the inability for a man to achieve and maintain an erection. Erectile dysfunction currently affects about 150 million men worldwide and this figure is expected to increase to about 322 million in 2025.
The problem with erectile dysfunction has to some extent been addressed in connection with the market introduction of drugs based on so-called PDE5 inhibitors (PDE5i), such as sildenafil, vardenafil and tadalafil. The most well-known drug in this category, sildenafil, is marketed under the brand name Viagra®; this drug also constitutes the treatment currently recommended for the symptom. These drugs usually have good effects but also suffer from a major problem – about 30 – 40 percent of the men who suffer from erectile dysfunction do not respond to treatment with this type of drug.
The patient group that may be resistant to PDE5i treatment for erectile dysfunction includes patients with neurological damage, diabetes and severe cardiovascular disease (organic erectile dysfunction). Other groups that may be resistant to PDE5i treatment include, among others, patients who are being treated with certain antidepressants and have psychological disorders (psychogenic erectile dysfunction). Among young men, about 14 – 35 percent, experience erectile dysfunction, which may also be due to psychiatric reasons e.g. performance anxiety when the man is too nervous to maintain an erection, or the result of side effects of specific drugs treating e.g. depression, schizophrenia and other mental disorders. Thus, there is a great unsatisfied medical need and thus also a need for an alternative treatment for erectile dysfunction that can satisfy the group of patients who are resistant to the treatment that is currently recommended. This group is the company’s primary target group.
Organic erectile dysfunction are best characterized by:
- Physical impairment of the delivery of adequate blood flow to the erectile tissue of the penis
- As much as 80% of ED is accounted for by organic causes (vasculogenic, neurologic, endocrinologic)
- Usually, the result of an underlying medical condition affecting blood vessels or nerves supplying the penis
- Gradual onset, incremental loss, lack of morning erections
Psychogenic erectile dysfunction are best characterized by:
- Persistent inability to achieve/maintain erection predominantly due to psychological factors
- Psychological factors (stress, anxiety, depression etc.) are responsible for about 20% of all cases of or ED
- Newly identified causes include relationship problems, feelings of guilt, and addiction to pornography
- Sudden onset, immediate loss, nocturnal and morning erections are possible