AbbVie’s oral medication Orilissa (elagolix) has won approval from Health Canada to treat moderate to severe pain caused endometriosis.
Orilissa is expected to reach Canadian retail pharmacies early next month.
“Endometriosis causes a significant impact on the quality of life of woman because of the debilitating and incapacitating pain. Women living with endometriosis can be sidelined by the disease,” Nicholas A. Leyland, MD, and chair of the obstetrics and gynecology department at McMaster University, in Hamilton, Ontario, said a press release. “Since there is no cure, the goal of treatment is to alleviate the symptoms and improve a woman’s quality of life. With Orilissa, we are now able to offer our patients an additional new option that can help them resume living their lives.”
Orilissa’s approval was supported by data from two studies (NCT01620528 and NCT01931670) in the largest endometriosis Phase 3 study program ever conducted. The studies included 1,689 women
The results of the studies — which included 1,689 women with moderate to severe endometriosis pain — indicated that three out of four patients taking 200 mg of Orilissa twice a day experienced a significant reduction in the three most common endo symptoms: daily menstrual pelvic pain (dysmenorrhea), non-menstrual pain, and pain during sex.
Women taking 150 mg of Orilissa once a day also saw their symptoms reduced. These results also dictated the approval of Orilissa by the U.S. Food and Drug Administration
Doctors recommend Orilissa for up to 24 months for the 150 mg once-daily dose and up to six months for the 200 mg twice-daily dose, as it causes a dose-dependent reduction in bone mineral density (BMD). The more Orilissa a woman takes, the higher her levels of BMD loss. Stopping the treatment may not be enough to completely reverse this effect.
“The approval of Orilissa demonstrates AbbVie’s continued commitment to women living with endometriosis,” said Stéphane Lassignardie, general manager of AbbVie Canada. “We are proud of our heritage in women’s health and strive to fill the unmet medical need by providing a safe and efficacious treatment.”
Endometriosis affects up to one in 10 women of reproductive age. Seven of 10 women taking medication for endometriosis still experience pain throughout the month.
“Endometriosis is a complex and incurable disease. This is why early diagnosis is extremely important. Currently, on average, it takes seven to nine years of complaining about symptoms to medical professionals to receive a diagnosis of endometriosis. Therefore, earlier diagnosis and treatment can help mitigate years of unnecessary suffering,” sai Philippa Bridge-Cook of Endometriosis Network Canada. “In addition, patients coping with symptoms without a diagnosis can sometimes face dismissal of their symptoms from friends, family and even medical professionals. This can lead to feelings of isolation, anxiety and depression.”
Orilissa is a short-acting small molecule that acts as antagonist of the gonadotropin-releasing hormone (GnRH) receptor, a protein involved in the release of follicle stimulating hormone (FSH) and luteinizing hormone (LH) 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.
The medicine induces a dose-dependent suppression of FSH and LH levels, reducing blood levels of the ovarian sex hormones, progesterone and estradiol. Such hormones are known to worsen endometriosis symptoms and quality of life.