|iX Biopharma's drug for treating male erectile dysfunction has just been approved for sale in Singapore.
The product, Silcap®, has obtained approval and registration by the Health Sciences Authority, says Singapore-listed specialty pharmaceutical company iX Biopharma.
There is already a variety of generic treatment options but Silcap® is designed as a novel small capsule, unlike existing alternatives which are typically delivered in tablet form.
Silcap® is the first capsule sildenafil product to obtain marketing approval in Singapore.
Silcap® is iX Biopharma’s second drug for the treatment of male erectile dysfunction after Wafesil®.
The latter is a novel dose form of sildenafil delivered using iX Biopharma’s proprietary WaferiX® drug delivery technology, a sublingual wafer that delivers drug actives safely, conveniently and rapidly into the blood stream.
iX Biopharma also supplies Silcap® and Wafesil® in Australia since obtaining approval and registration in 2018 from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia.
|Ms Eva Tan, Director, Corporate and Commercial Strategy of iX Biopharma, said: “We are delighted with the approval and registration of Silcap® in Singapore. Apart from offering a unique value proposition when compared to existing sildenafil products in the market, Silcap® ’s approval continues to reaffirm our ability to bring products successfully from clinical development to registration and launch.”|
Silcap® is available in dosage strengths of 25 mg and 50 mg in pack sizes of 4, 8 and 12 capsules.
iX Biopharma will be preparing for marketing launch of Silcap® in Singapore.
As sildenafil drugs are classed as prescription medication in Singapore, Silcap® will be supplied via licensed medical practitioners.
|iX Biopharma cited a study that said erectile dysfunction is a common condition affecting one in five men over the age of 40 years 1.
In a population-based survey conducted in Singapore on men greater than 30 years old, a prevalence rate of male erectile dysfunction of 51.3% was observed, whereas another study on the ageing population in the country reported a prevalence rate of 73.0% 2.
1 “Assessment and Management of Infertility at Primary Healthcare Level”, Academy of Medicine Singapore, 2013
2 “Male sexual dysfunction in Asia”, Asian Journal of Andrology, 2011
Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance, and these problems may be related to a wide variety of factors.
Erectile dysfunction is common among older men and is often associated with chronic illnesses including atherosclerosis, diabetes and depression. It is also associated with certain prescription medications and alcohol consumption.