Data from Pharmawand - Curated by EPG Health - Date added 06 February 2020
Contura announces that on January 28 2020 it received official notification from the FDA that the premarket approval application (“PMA”) for Bulkamid has been approved. Bulkamid is Contura’s proprietary medical device and its approved indication in the US is for the treatment of stress urinary incontinence (“SUI”) due to intrinsic sphincter deficiency in adult women who have SUI or stress predominant mixed incontinence.
Bulkamid is currently marketed in more than 25 countries throughout the world. The pivotal North American study reporting on the efficacy and safety of Bulkamid for the treatment of female stress incontinence formed the basis of Contura’s PMA.
The US approval comes on the back of recent evidence showing that when women with SUI are given a choice of treatments, their preferred option is urethral bulking. The minimally invasive Bulkamid treatment is increasingly being used in Europe and now represents the number one SUI treatment in the UK after conservative measures such as physiotherapy. In the US, many hundreds of thousands of women are diagnosed with SUI annually, but only a small proportion are treated.
Comment:Bulkamid was approved in Canada in May 2018 and is distributed there by Searchlight Pharma.