For those who suffer from an overactive bladder, the FDA may be offering hope with a new mode of treatment. The agency has just recently approved a supplemental New Drug Application (sNDA) for mirabegron (Mybetriq) as a combination therapy with muscarinic antagonist solifenacin succinate (VESIcare) for the treatment of overactive bladder (OAB).
The new treatment was added to the list of other combination therapies to treat symptoms of OAB.
Approval was based on results of a three-phase trial. In SYNERGY 1 and 2, which included over 9,000 patients who were administered either mirabegron and solifenacin succinate, monotherapy of either drug or placebo, to test for safety profile.
For phase three of the BESIDE study, 2,174 patients were enrolled from 31 countries to study efficiency. They received the set-dose regimen versus sole doses of 5 mg and 10 mg solifenacin succinate.
There is a strong need to develop effective treatments for overactive bladder as cases are on the rise. An estimated 546 million people are affected by OAB in a year.
When the bladder sends wrong signals to the brain, that triggers the urgency to urinate regardless if the bladder is full or not.
Carol Schermer from Astellas Pharma concluded, “OAB patients may have symptoms that are not fully managed with their current treatment. With the FDA approval of Myrbetriq in combination with solifenacin succinate, Astellas is able to offer an additional treatment option to individuals living with symptoms of OAB.”
In the meantime, if you suffer from overactive bladder, it’s important to speak to your doctor as some treatments are currently available that may offer you some form of relief.
Share this information