Overactive bladder and Myrbetriq

The U.S. Food and Drug Administration recently approved Myrbetriq to treat adults suffering from overactive bladder.

According to the FDA’s website, “Overactive bladder is a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.”

MedicineNet states that 1 in 11 U.S. adults suffer from overactive bladder. The condition may feel crippling – or at least embarrassing – given symptoms that include:

• Urinating too often
• The urgent need to urinate
• Involuntarily leaking urine resulting from the urgent need to urinate

“An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious,” said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Astellas Pharma markets Myrbetriq, which is a once-daily drug that increases the bladder’s storage capacity. Myrbetriq also relaxes the bladder muscle as it’s being filled to a higher volume. The newly-approved drug provides another option in addition to anticholinergics like Vesicare and Detrol to ease the discomfort of overactive bladder.

Study proves Myrbetriq’s usefulness

The drug was approved after a myriad of clinical trials. Three double-blind studies were conducted in which placebos were used. According to the FDA, over 4,000 patients suffering from overactive bladder took either a placebo once daily for 12 weeks or Myrbetriq in multiple dosages ranging from 25 milligrams to 100 milligrams.

This study showed that Myrbetriq at 25 mg and 50 mg dosages reduced urination and wetting accidents over 24 hours. Results also illustrated that participants taking a 50 mg dose tended to release an increased amount of urine, proving Myrbetriq’s ability to increase the bladder’s storage capacity.

According to the FDA, the most common side effects found with the Myrbetriq study were:

• increased blood pressure
• cold-like symptoms
• urinary tract infection
• constipation
• tiredness
• increased heart rate
• abdominal pain

At the conclusion of the trials, it was determined that Myrbetriq should not be used by patients with severe high blood pressure, especially if it is not properly controlled. Patients in the final stages of kidney disease or those with serious liver damage are also not recommended to take the drug.