New Endometriosis Drug Shows Success in Phase 3 Trials

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Source: Freepik

Linzagolix, a new endometriosis drug, helps reduce pain, excessive bleeding, and constipation among women part of a phase 3 trial.

Earlier this month, the biopharmaceutical company, ObsEva announced phase 3 trial results of linzagolix. The oral GnRH (gonadotropin-releasing hormone) receptor antagonist has previously treated heavy menstrual bleeding associated with uterine fibroids. Now, the Phase 3 EDELWEISS 3 trial of linzagolix aims to assess the efficacy of the new endometriosis drug in reducing menstrual pain. Recently, ObsEva announced the results of the trial in a press release.

Endometriosis is a debilitating chronic disease that roughly affects 10% of the world’s women and girls of reproductive age. Presence of endometrial tissue outside the uterus results in a wide variety of symptoms. This includes painful periods, pelvic pain, abdominal bloating, pain during sexual intercourse, painful bowel movements, fatigue, depression, and even infertility. Several surgical and non-surgical treatment options are available for the condition. However, the available medical treatment options cause significant side effects and are not suitable for long-term use. Therefore, there is a need for effective and safe non-invasive options for women suffering from endometriosis.

While there have been recent advances in non-surgical endometriosis treatment, there is still a critical need for therapeutic options for women who suffer from this chronic condition.

Dr. Hugh Taylor, Professor and Chair of Obstetrics and Gynecology at Yale University

Phase 3 EDELWEISS 3 Trial

The Phase 3 trial compared the efficacy of linzagolix in women with moderate-to-severe endometriosis-associated pain. Researchers administered the drug either alone or in combination with add-back therapy (ABT). In ABT, the medication is given with a small dosage of progesterone with, or without, estrogen.

According to the results, 200mg of linzagolix with ABT caused a significant reduction in pain, constipation, and excessive menstrual bleeding among the participants. Moreover, women in this group reported an increased ability to take part in daily activities during their periods. Researchers also noted minimal impact on the participants’ bone density. Thus, making it a good candidate for younger women suffering from endometriosis.

Availability of medical therapies that can be used long-term is important for this typically younger patient population.

Dr. Hugh Taylor, Professor and Chair of Obstetrics and Gynecology at Yale University

Although the 75mg drug dosage without ABT also reduced bleeding, it did not cause a significant reduction in menstrual pain.

This is the first medication of this kind that has managed to address constipation, a common and often debilitating symptom of endometriosis. Linzagolix is not yet approved for use against the disease; however, the trial’s results bring it one step closer to approval.

Source: ObsEva

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