Therapeutic Areas

IBSA expands solutions in male sexual health in the US with new FDA approval

Erectile dysfunction (ED) is a highly prevalent yet often under-recognised condition. In the United States, it is estimated to affect approximately 24% of the male population, with prevalence increasing with age.1 However, ED is not exclusively age-related: in recent years, a growing incidence has also been observed among younger individuals, underscoring the importance of healthy lifestyle habits and regular physical activity in reducing the risk of developing the condition.1

THE CAUSES OF ERECTILE DYSFUNCTION

The etiology of erectile dysfunction is multifactorial, with numerous and often concomitant causes. Organic factors primarily involve vascular, neurological, and hormonal components, with atherosclerosis, diabetes mellitus, and hypogonadism representing key pathogenic mechanisms. Alongside these, psychogenic factors continue to play a significant role, interacting with biological determinants in the onset and persistence of ED.2

Given this complexity, therapeutic solutions characterised by simple and discreet administration routes are particularly valuable, as they support treatment adherence and facilitate the management of the condition.

FDA APPROVES IBSA NEW SILDENAFIL ORAL FILM

Male sexual health in the US

 

The Food and Drug Administration (FDA) approval has been granted for sildenafil oral film. Oral films dissolve rapidly in the mouth without the need for water after placing on the tongue. This has the advantage for patients of being practical and discreet, allowing self-dosing in advance of clinical need.

CONTINUOUS INNOVATION TO ADDRESS UNMET CLINICAL NEEDS

With a focus on addressing unmet clinical needs, IBSA continues to invest in the development of its portfolio. IBSA has progressively expanded its activities within the urology area across several European countries, with Italy among the earlier markets and the United Kingdom among the more recent. Further geographic expansion is anticipated in line with the company’s strategic development plans.

 

References 

1Mark KP, et al. J Sex Med. 2024 Mar 28;21(4):296-303. 

2Mazzilli F. J Clin Med. 2022 Oct 30;11(21):6429.