Mirabegron for OAB Now Available in Canada


FDA Approved June 2012 Mirabegron 223673-61-8Canadian Patients got good news on April 10, 2013 when the availability of Mirabegron for OAB (Overactive Bladder) was announced. “Now that Myrbetriq is available through pharmacies, Canadian patients have access to the first new class of medication for the treatment of OAB in over 30 years,” said Michael Tremblay, President, Astellas Pharma Canada, Inc.  Astellas Pharmaceuticals markets mirabegron as the brand name Myrbetriq, which was approved by the FDA in June 2012.

Mirabegron for OAB is novel as it is the first oral OAB treatment with a unique mechanism of action since the advent of anticholinergic medications over 30 years ago. Approved on June 28, 2012 mirabegron CAS# 223673-61-8, is used to treat the symptoms of OAB, such as urge urinary incontinence, urgency, and urinary frequency.  As an extended-release tablet to be taken once daily, Mirabegron is a beacon of hope for an estimated 33 million Americans and 2.9 million Canadians suffering from Overactive Bladder.

Over 10,000 patients in the past decade have participated in studies of Myrbetriq. There were three notable and successful double-blind, multicenter and placebo-controlled clinical trials involving 4,116 patients with OAB. The patients in these studies were randomly assigned to take either Myrbetriq or a placebo for a period of twelve weeks. The doses of Mirabegron (Myrbetriq) were 25 milligrams, 50 milligrams or 100 milligrams. The results from this study were encouraging and optimistic, demonstrating that patients who took doses of both 25 milligrams and 50 milligrams were able to significantly reduce their number of wetting accidents. Patients who were dosed with the 25 milligram and 50 milligram doses also noted a reduction of times urinated in a 24 hour period. Furthermore, the patients who took the 50 milligram dose of Mirabegron were capable of expelling a substantial amount of urine, which proved this medication’s effectiveness in improving the storage capacity of the bladder.

Male Bladder Female Bladder IllustrationMirabegron has a distinct mechanism of action which helps to increase the bladder capacity of the patient by relaxing their detrusor smooth muscle. The relaxation of the detrusor smooth muscle occurs during the storage phase of the patient’s urinary bladder fill-void cycle. By relaxing and quieting the bladder the capacity to hold liquid is increased, leading to improved symptoms of OAB in patients.

The patent for Myrbetriq will expire for Astellas on October 15, 2018. LGM Pharma provides API Mirabegron for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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