This Notice of Compliance is the culmination of Duchesnay's efforts following the signing of an agreement with the family-owned German pharmaceutical company, Apogepha, specialized in Urology. Duchesnay has also signed an agreement to market Mictoryl® in the United States through its subsidiary, Duchesnay USA, once all FDA regulatory reviews have been completed.
"OAB is a serious medical condition that affects millions of Canadians each year, including children. However, the medications currently available cause significant side effects, leading many patients to stop treatment. That's why Duchesnay is so pleased to offer this new therapeutic option, which is also indicated for pediatric use," explained Éric Gervais, Executive Vice President of Duchesnay.
According to the Canadian Continence Foundation, OAB is a medical term that describes various symptoms caused by involuntary bladder spasms, including urinary frequency, especially at night, and urgency with or without involuntary leakage. These symptoms may occur without obvious cause or be secondary to certain diseases of the nervous system. The Foundation estimates that nearly 1 in 5 Canadians over the age of 35 suffers from overactive bladder. The condition, with frequency and urgency only, affects men and women of all ages, although most are under age 65.*
"Health Canada's approval of Mictoryl® confirms its excellent safety and efficacy profile in both adults and children. Knowing that this product is about to be launched in North America is a groundbreaking step for Apogepha and demonstrates our ability to leverage our international footprint. We are proud to partner with Duchesnay to bring this product to market," commented Markus Bauer, Managing Director of Apogepha.
Mictoryl® is used to treat adults who have difficulty controlling their urinary function due to bladder overactivity and who have symptoms of urinary urgency, frequency or incontinence. Mictoryl® will be available in 30 mg and 45 mg modified-release capsules and is indicated for adults, including those over 65 years of age.
Mictoryl® Pediatric is used to treat children who have difficulty controlling their urinary function due to bladder overactivity and who have symptoms of urinary urgency, frequency or incontinence. Mictoryl® Pediatric will be available in 5 mg tablets and is indicated for body-weight-adjusted dosing in children 5 years of age who weigh over 35 kg. Children and adolescents with a higher body weight will be prescribed a daily dose of 30 mg propiverine.
Duchesnay is a specialty pharmaceutical company with a long-standing commitment to women's health. In addition to filling the void in terms of scientific research, education and information and developing pharmacological solutions that are safe for use during pregnancy and breastfeeding, Duchesnay is equally committed to ensuring women's health and improving their quality of life at every stage.
Thus, Duchesnay has broadened its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives. To learn more about Duchesnay, visit duchesnay.com.
Apogepha is an independent German pharmaceutical company that specializes in the field of Urology. The company has its own production facilities and developed propiverine, one of the leading medicines for the treatment of overactive bladder in adults and children. Various dosages and formulations of propiverine are available worldwide under trademarks such as Mictonorm® and Detrunorm®. The patent for the once-daily formulation of propiverine has been approved in most countries. Currently, Apogepha has marketing and distribution partners in more than twenty countries, with a focus on Europe and Asia. To learn more about Apogepha, visit www.apogepha.com.
*The Canadian Continence Foundation: http://www.canadiancontinence.ca/EN/types-of-urinary-incontinence.php
SOURCE Duchesnay inc.
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