Orilissa was previously available in Canada in either a 150 mg or 200 mg dose, taken once a day with or without food.
The approval of the 200 mg twice-daily dose is based on data from two Phase 3 studies — the Elaris EM-I study (NCT01620528) and the Elaris EM-II study (NCT01931670) — which evaluated 1,689 women with moderate to severe endometriosis pain, making it the largest Phase 3 program on endometriosis to date.
Both trials evaluated the effects of two doses of Orilissa, 150 mg once daily and 200 mg twice daily, compared with a placebo. The researchers assessed the effects of Orilissa on daily non-menstrual pelvic pain and menstrual cramps before treatment, and at three and six months after treatment.
Both doses significantly reduced the women’s non-menstrual pelvic pain and menstrual cramps at three and six months. The 200 mg dose of Orilissa significantly reduced pain associated with sexual intercourse in the third month after the start of treatment.
Both doses caused side effects such as hot flushes and a decrease in bone thickness, known as bone mineral density. However, these effects were consistent with the partial hormone suppression associated with the treatment’s mechanism of action.
The six-month trials were followed by two Phase 3 extension studies — Elaris EM-III (NCT01760954), an extension of Elaris EM-I, and Elaris EM-IV (NCT02143713), an extension of Elaris EM-II — which evaluated the long-term safety and efficacy of Orilissa (total treatment period was one year). Patients received doses of 150 mg once daily or 200 mg twice daily.
Results confirmed the benefits of Orilissa seen in the earlier trials, with the therapy reducing non-menstrual pelvic pain and menstrual cramps associated with endometriosis throughout the 12 months of treatment.
The 200 mg dose was better at reducing pain associated with intercourse after 12 months. No new safety concerns were seen with long-term use.
The recommended use for Orilissa is up to 12 months for the 150 mg once-daily dose and up to six months for the 200 mg twice-daily dose, as it leads to a decrease in bone mineral density, which “is greater with increasing duration of use and may not be completely reversible after stopping treatment,” stated the news release.
“We are proud to launch the Orilissa 200 mg strength. With this dose, we are able to offer physicians the unique ability to individualize the care of their patients. Women with endometriosis now have a hormone-free choice that is customizable based on their unique needs,” Stéphane Lassignardie, general manager of AbbVie Canada said in a press release.
Orilissa is a short-acting small molecule that works as an antagonist of the gonadotropin-releasing hormone receptor (GnRH), a protein involved in the release of follicle stimulating hormone and luteinizing hormone from the pituitary gland (the organ in the brain where these hormones are produced). Orilissa binds to GnRH receptors in the pituitary gland, blocking GnRH action and ultimately leading to reduced ovarian production of the sex hormones, estradiol and progesterone.
“Although endometriosis is currently incurable, there are effective treatments available and in partnership with their healthcare professionals, patients can work on a treatment plan that works for them. Ultimately, we know what people living with this debilitating disease want is to live fulfilling and pain-free lives, where they are able to pursue any endeavour, both professionally and personally,” said Philippa Bridge-Cook, PhD, executive director of The Endometriosis Network Canada.
Added Jamie Kroft, MD, FRCSC, an assistant professor at Sunnybrook Health Sciences Centre: “The women I see in my practice always have a lot of questions, especially around appropriate medical management. I take the time to explain their options so they can make an informed decision. Therefore, the more options that are available, for example ones that are hormone-free and can be customized to my patients’ needs, the better I can treat them. Women should not suffer in silence, especially not when there are new treatment advances.”