MedicalResearch.com Interview with:
Dr. Dawn Carlson MD MPH
Vice President, General Medicine Development
MedicalResearch.com: Please provide some background on this announcement. Would you briefly explain what endometriosis is? Whom does it affect and how does it interfere with quality of life?
Response: Endometriosis is one of the most common gynecologic disorders in the U.S that affects an estimated one in 10 women of reproductive age. It occurs when tissue similar to the lining of the uterus starts growing outside of the uterus, where it doesn’t belong.
The symptoms of endometriosis, including pain with menstrual periods and between periods, and with sexual intercourse, can be debilitating and significantly impact day-to-day activities of women’s lives, personally and professionally. Unfortunately, women with endometriosis can suffer for up to 10 years and visit multiple physicians before receiving a proper diagnosis. Unresolved endometriosis pain results in higher healthcare costs from emergency department visits and repeat surgeries.
MedicalResearch.com: What are the main findings of studies to date?
Response: The clinical trial program for ORILISSA represents two robust replicate studies in the largest endometriosis Phase 3 study program conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. Clinical trial data demonstrated ORILISSA significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex. Adverse events associated with reduced estradiol levels were also observed, including hot flushes, a dose-dependent decrease in bone mineral density and increases in serum lipid levels.
MedicalResearch.com: For whom would Orilissa be recommended?
Response: Every woman is different, so it’s essential to provide physicians and women living with endometriosis with several treatment options. Endometriosis-associated pain is often managed with medicines such as oral contraceptives, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids and hormonal therapies, which can work for some women but very few of these treatments are specifically indicated for the treatment of endometriosis. In more extensive cases, surgical interventions are often pursued, and may not be curative for all individuals.
ORILISSA is the first and only oral GnRH antagonist specifically developed for women with moderate-to-severe endometriosis pain. It works by a mechanism of action that partially lowers the level of ovarian sex hormones in the body, which has the potential to reduce side effects associated with reduced estrogen, such as hot flush and bone mineral density changes. ORILISSA is available in two oral dosages, which allows physicians to individualize treatment based on a woman’s specific type and severity of endometriosis pain.
MedicalResearch.com: What should readers take away?
Response: Current treatment options for endometriosis are limited and there have been few treatment advancements in decades, making the ORILISSA approval a significant step forward for women with endometriosis who need more options for the management of the condition.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: We expect ORILISSA to be available in U.S. retail pharmacies in early August 2018
Disclosures: am employed by AbbVie.
AbbVie Receives U.S. FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
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