Health Canada approves Knight Therapeutics' Imvexxy for vaginal atrophy
Canadian regulators have cleared the estradiol-based treatment for postmenopausal women suffering from moderate to severe dyspareunia.
Health Canada has approved the use of Imvexxy, an applicator-free estradiol vaginal insert, for the treatment of moderate to severe dyspareunia in postmenopausal women. The condition, a symptom of vulvar and vaginal atrophy, causes significant discomfort and pain during sexual activity.
Knight Therapeutics secured the rights to market the drug in Canada under a 2018 licensing agreement with Florida-based TherapeuticsMD. This agreement grants Knight exclusive commercialization rights for both Imvexxy and Bijuva within the Canadian market.
Under the financial terms of the deal, Knight is obligated to provide milestone payments to TherapeuticsMD following the Canadian regulatory approval. Future revenue will be subject to sales-based royalties. Imvexxy is already available to patients in the United States.