- Contura has earned FDA approval for an injectable hydrogel to treat stress urinary incontinence in women, according to a premarket approval order posted by the agency Monday. The permanently implanted device acts as a scaffold for cells to grow through, supporting the closing mechanism of the urethra for better control of urine.
- Approval of the Bulkamid implant was based on a study of 228 women that showed 75% of those who got the device reported dryness or improvement in their symptoms.
- Contura expects to launch the device in the U.S. in the first quarter of 2020.
Stress urinary incontinence can occur when the pelvic floor muscles have stretched, allowing urine to leak during physical activity such as walking, bending or coughing. Available treatments for urinary incontinence range widely, from pelvic muscle strengthening exercises to Botox injections and surgical mesh, according to the Mayo Clinic.
FDA approved Bulkamid, which it said is marketed in more than 20 countries, to treat stress incontinence due to intrinsic sphincter deficiency. The agency received London-based Contura’s premarket approval application in July 2017 and gave its OK for the device last week.
Contura suggested that women may have concerns about some available treatments for the condition, and the company is hoping the safety and effectiveness profile of Bulkamid will attract patients to its new product.
Bulkamid consists of 2.5% polyacrylamide and 97.5% water and is injected with a syringe. In the clinical study supporting FDA’s approval, the level of improvement in women’s symptoms was found to be similar to another FDA-approved bulking agent, a collagen treatment from Allergan, according to the agency’s labeling information for the Contura device. AbbVie is in the process of acquiring Allergan for $63 billion.
Contura’s clinical trial showed that at 12 months, 46.9% of Bulkamid patients met the study's effectiveness endpoint of reduction in the amount and frequency of involuntary urine loss.
One serious adverse event, blood in the urine, reported in the clinical study, was thought to be related to the procedure and not to the gel, according to FDA’s labeling information.
More than 70,000 women with stress urinary incontinence over 10 years have been treated with Bulkamid with no reported long-term complications, the labeling said. The most common side effects reported were pain, acute urinary retention and urinary tract or bladder infection, and the issues typically resolved themselves in a few days.
Contura said it will launch the device in the U.S. at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction meeting in late February in Scottsdale, Arizona.