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FDA approves Vesicare (solifenacin succinate) for the treatment of overactive bladder

July 11, 2017

In clinical studies, Vesicare 5 mg and 10 mg showed clinical and statistical improvements in all symptoms of OAB. Specifically, once-daily Vesicare was found to significantly reduce the number of incontinence episodes for patients during a 12-week study period.

OAB is a medical condition that causes the bladder muscle (known as the detrusor muscle) to contract while the bladder is filling with urine, rather than when the bladder is full. Patients with OAB feel the urge to urinate more often, without advance warning, and when the bladder isn't completely full. This results in a patient experiencing urgency (an immediate and strong sense to urinate), frequency (the need to frequently go to the bathroom), and for many, urge incontinence (an involuntary loss of urine).

"A key concern for OAB patients is the very real fear of having an accident in public," said, Peter Sand, MD, Director of Urogynecology, Northwestern University. "The approval of Vesicare is important because it offers patients a treatment with a favorable safety profile that reduces symptoms-in particular the chance of accidental leaks."

While OAB affects an estimated 17-20 million men and women in the United States, few understand that it is a treatable condition. Many mistakenly believe this is a natural part of aging, are embarrassed to discuss it, or believe there is no treatment option available. Therefore, patients gradually develop coping behaviors to manage their symptoms. These coping mechanisms include restricting fluids, carrying extra clothing, "mapping" bathroom locations, or even choosing not to leave the house. None of these behaviors, however, are clinically proven to be successful in treating the symptoms of OAB.

The debilitating effects of OAB exact not only a physical, social, and emotional toll on patients, but a financial one as well. It is estimated that costs related to OAB were nearly $14 billion in the United States in 2000, similar to that of gynecological and breast cancers, osteoporosis, or arthritis.

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"Considering the increasing incidence of OA (osteoarthritis) in the elderly population, pain-reducing medications such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAID), and COX-2 inhibitors have been common treatments. However, prolonged intake of NSAID increases the risk of gastrointestinal side effects and renal toxicity, and may inhibit synthesis of cartilage matrix," the researchers noted in their published report.

"There is a need for alternative products that benefit patients with OA without harmful side effects," they added. "The results of this study provide support for the use of cetylated fatty acids as part of a pain relief treatment in patients with knee OA."

Capsule study: In the case of the capsules containing cetylated fatty acids, the double-blind, placebo-controlled study published in 2002 evaluated 64 patients who were asked to consume six real or placebo capsules per day for 68 days. Patients were asked to maintain their daily medication routines, including any prescription medications they might be taking to treat their osteoarthritis.

After 68 days, researchers found that patients treated with the capsules containing cetylated fatty acids exhibited greater improvement in knee range of motion and overall function than those who were treated with placebo. "The CFA (cetylated fatty acids) provided relief even for those individuals also receiving traditional medications," the researchers reported.

"Our results suggest that cetylated fatty acids are effective in improving the symptoms of OA and therefore should be considered as a viable option for treatment of this condition," they concluded.

Complete texts of both studies can be found at celecaine/.