News & Events
Estragyn Vaginal Cream™ 0.5 gram low dose added to Health Canada-approved product monograph
Montreal, QC. Searchlight Pharma is pleased to announce an amendment to the approved product monograph for Estragyn Vaginal Cream™ that reduces the starting dose to 0.5 grams from the previously approved 2 grams. Effective immediately, the approved dose for Estragyn Vaginal Cream™ is 0.5 to 4 grams per day taken intravaginally, adjusted to the lowest amount that controls symptoms. The lowering of the dosing range to begin as low as 0.5 grams follows the issuance of a “No Objection Letter” by Health Canada’s Therapeutic Products Directorate to an application filed by the company, and conforms with the recommendation of an independent clinical expert report from the Society of Obstetricians and Gynaecologists of Canada (SOGC). The revised product monograph reflecting the newly approved low dose can be accessed and reviewed at www.searchlightpharma.com/app/uploads/2016/04/Estragyn-Updated-PM_Apr8-16.pdf
“The SOGC has been a consistent proponent of treatment guidelines that reflect the state of the art in clinical practice, and that promote and support the usage of the lowest effective dose of estrogen to adequately manage individual symptoms of vulvovaginal atrophy (VVA)”, said Dr. Jennifer Blake, CEO of the SOGC. “Many postmenopausal women unnecessarily suffer the symptoms of VVA, despite the well-known efficacy and safety of local estrogen therapy.”
“The approval of the 0.5 gram starting dose is a significant step in further encouraging Canadian women and healthcare professionals to use the lowest effective dose of local estrogens in the treatment of VVA,” said Mark Nawacki, President and CEO of Searchlight Pharma. “There has been consistent, well-accepted recognition in clinical research outcomes, clinical practice, and national and international treatment guidelines, that the adoption of the lowest effective dose of local estrogen treatments for the management of VVA is best practice. We are pleased to have played a positive role in guiding this same move towards lower dosing with Estragyn Vaginal Cream™, and to have helped to clarify the optimal dosing approach with this important treatment option for VVA.”
About Estragyn Vaginal Cream™
Estragyn Vaginal Cream™ is a prescription topical cream indicated for the treatment of the symptoms of vulvovaginal atrophy due to estrogen deficiency. It is the only non-animal derived, single ingredient topical product approved by Health Canada used to treat the dryness, itching and burning in and around the vagina due to a lack of estrogen. Containing 0.1% of estrone, a naturally occurring estrogen in the female human body, Estragyn Vaginal Cream™ is an alcohol-free, fragrance-free topical alternative to other local estrogen formulations available in Canada.
For more information about Estragyn Vaginal Cream™ or this regulatory update please contact Mark Nawacki at (514) 613-1513 or at email@example.com.