New Overactive Bladder Drug Myrbetriq Gets FDA Nod

Myrbetriq, a drug, which offers new treatment option for overactive bladder (OAB), has been recently approved by the US Food and Drug Administration (FDA).

Overactive bladder is a condition in which the urinary bladder muscle loses control and causes the bladder to contract at inappropriate times. Overactive bladder symptoms, such as urinary incontinence, urgency to pass urine and frequent urination, can now be treated with this new drug, which is a proud product of the pharmaceutical company, Astellas Pharma US, Inc.

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Myrbetriq may be administered orally, 25 mg, once daily, with or without food. In most cases it is effective in about eight weeks. The dose may be increased to 50 mg, depending on the patient’s need and tolerability.

Steven Ryder, MD, president, Astellas Pharma Global Development said, “Myrbetriq is the first oral OAB therapy with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago.” “The approval of Myrbetriq represents an important milestone in OAB treatment and in our ongoing commitment to advancing urological health.”

OAB is currently treated with Antimuscarinics, which binds to muscarinic receptors in the bladder and prevents involuntary bladder contractions.

Myrbetriq has a unique mode of action. It activates the beta-3 adrenergic receptors and relaxes the detrusor smooth muscle, thereby increasing the bladder capacity and reducing the feeling of urgency to urinate.

Victor Nitti, MD, professor of Urology and Ob/Gyn, vice chairman, Department of Urology and director of Female Pelvic Medicine and Reconstructive Surgery NYU Langone Medical Center said, “OAB impacts each individual differently so it is important to have a variety of treatment options available,”

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Astellas has carried out extensive research on this drug through studies involving more than 10,000 individuals for over a period of 10 years.

The subjects were primarily Caucasians females, with a mean age of 59 years. It included those who were treated earlier with antimuscarinic pharmacotherapy and those who were not treated.

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After treatment with myrbetriq, researchers noted a significant decrease in incontinence episodes and frequency of urination. On an average, the number of urinations reduced by 1.75 from a baseline of 11.70 urinations.

The most common side effects of the drug were hypertension, nasopharyngitis, headache, dry mouth, memory issues and urinary tract infections.

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Myrbetriq will be supplied in the form of 25 mg and 50 mg tablets and is expected to hit the US market later this year. It has already been approved in Japan and is currently being reviewed in other countries as well.

Those patients who do not respond well to OAB medications or suffer from side effects must follow some life style changes such as avoiding tea, alcohol or soda and doing kegel exercises.

Source-Medindia