Endometriosis ~ Abdominal Pain ~ Endo ~ Scar Tissue ~ Adhesions ~ Infertility ~ Hysterectomy

Wednesday, November 30, 2011

Notice of Decision for Pr VISANNE® Canada

Notice of Decision for PrVISANNE®Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 23 K)
Contact: Bureau of Metabolism, Oncology and Reproductive Sciences

Date issued: November 7, 2011

On October 12, 2011, Health Canada issued a Notice of Compliance to Bayer Inc. for the drug product, Visanne.

Visanne contains the medicinal ingredient dienogest which is a progestin.

Visanne is indicated for the management of pelvic pain associated with endometriosis. The efficacy of Visanne has not been tested beyond 15 months.

Endometriosis is a gynaecological disease where endometrial tissue is found outside the uterine cavity, most commonly on the ovaries and the peritoneal surface. This tissue can cause inflammation and adhesions which result in chronic pelvic pain and often infertility. The cause of endometriosis remains unknown. Visanne reduces the endogenous production of estradiol and thereby suppresses the trophic effects of estradiol on both the eutopic and ectopic endometrium. When given continously, Visanne leads to a hyperprogestogenic and moderately hypoestrogenic endocrine environment causing initial decidualization of endometrial tissue. In addition to the estradiol-mediated effects Visanne also has direct antiproliferative, immunologic and antiangiogenic effects that contribute to the reduction of pelvic pain associated with endometriosis.

The market authorization was based on quality, non-clinical, and clinical information submitted. The efficacy and safety of Visanne were demonstrated primarily in three multicentre Phase III studies. All three studies enrolled patients with a confirmed diagnosis of endometriosis with various stages of disease severity. Assessment of pelvic pain associated with endometriosis was determined by using a visual analog scale (0-100 mm, where 0 mm represents no pain and 100 mm represents severe pain). The first study was a double-blind placebo-controlled study where 102 patients were treated orally (PO) with a Visanne 2 mg tablet once daily (OD) compared to 96 patients who were treated with a placebo, over a 12 week period. The second study was an open-label extension to the placebo-controlled study. The extension study included 168 women; 87 previously treated with Visanne (2 mg, PO, OD) and 81 previously treated with placebo. All 168 women received Visanne (2 mg, PO, OD) for an additional 52 weeks to assess the long-term efficacy of Visanne treatment. The third study compared Visanne (2 mg, PO, OD) to 3.75 mg leuprolide acetate administered intramuscularly every four weeks, where 120 patients received Visanne treatment and 128 patients received leuprolide acetate, for a 24-week treatment period. Results from all three studies demonstrated that treatment with Visanne produced clinically significant reductions in pelvic pain compared to baseline values. In the placebo-controlled study, following 12 weeks of treatment with Visanne, the mean reduction of pelvic pain compared to baseline was 27.4 ± 22.9 mm. The open-label extension study showed continued improvement in pelvic pain for up to 15 months. In the third active comparator study, Visanne demonstrated efficacy similar to leuprolide acetate in reducing pelvic pain associated with endometriosis. In all clinical studies, Visanne was generally well-tolerated.

Visanne (2 mg, dienogest) is provided in tablet form. The recommended dose of Visanne is one oral tablet per day, preferably taken at the same time each day, with some liquid as needed. Visanne tablets are intended for continuous administration regardless of any vaginal bleeding. Dosing guidelines are available in the Product Monograph.

Visanne is contraindicated in women with any of the conditions listed below, which are partially derived from information on other progestin-only preparations. Should any of the conditions appear during the use of Visanne, treatment must be discontinued immediately.

•Known or suspected pregnancy;
•Active venous thromboembolic disorder;
•Arterial and cardiovascular disease, past or present [for example (e.g.) myocardial infarction, cerebrovascular accident, ischaemic heart disease];
•Diabetes mellitus with vascular involvement;
•Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
•Presence or history of liver tumours (benign or malignant);
•Known or suspected sex hormone-dependent malignancies;
•Undiagnosed abnormal vaginal bleeding;
•Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields;
•Current or history of migraine with focal aura;
•Hypersensitivity to dienogest or to any ingredient in the formulation or component of the container.
Visanne should be administered under the conditions stated in the Product Monograph taking into consideration the potential risks associated with the administration of this drug product. Detailed conditions for the use of Visanne are described in the Product Monograph.

Based on the Health Canada review of data on quality, safety, and efficacy, Health Canada considers that the benefit/risk profile of Visanne is favourable for the indication stated above.

© 2011, Bayer Inc.
®VISANNE is a trademark used under license by Bayer Inc.

Notices of Decision (NDs) are produced in accordance with the Summary Basis of Decision (SBD) initiative. All NDs will be reproduced within the corresponding SBD, normally available within 5 months of product authorization.


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