Endometriosis is a painful and debilitating chronic inflammatory condition that affects roughly 10 percent (190 million) of reproductive-age women and girls globally, according to the World Health Organization. While severe disease can sometimes be managed with surgery, the condition is one in great need of an effective and appropriate medicinal therapy, but existing non-invasive treatments aren’t suitable for long-term use.
Now, a drug that tackles the pain, heavy bleeding, and constipation associated with endometriosis is looking like a hopeful candidate. Having shown positive results in a preliminary phase 3 trial, the medication known as linzagolix could take the place of elagolix and leuprorelin, two drugs that have to be stopped around the two-year mark to prevent serious side effects including bone density loss.
The novel therapy’s performance during the Phase 3 EDELWEISS 3 trial was reported by ObsEva, who found that a once-a-day treatment of 200mg linzagolix saw a reduction in pain, excessive bleeding, and constipation among people with endometriosis. The dosage included add-back therapy (ABT), which is when medication is supplemented with a small amount of progesterone with or without estrogen.
Compared to a placebo, the 200mg with ABT treatment proved to be a statistically significant influence on bleeding, pain, and constipation. The therapy was also found to have a meaningful impact on participants’ ability to go about their daily lives while experiencing endometriosis symptoms.
A treatment supplying 75mg linzagolix without ABT showed a meaningful change in bleeding but didn’t meet the study’s co-primary objective of significantly reducing pain.
“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,” said Dr Hugh Taylor, Professor and Chair of Obstetrics and Gynecology at Yale University, in a statement.
“Once-daily linzagolix 200mg with ABT demonstrated excellent efficacy along with minimal changes in bone mineral density, suggesting this dose may be used for long-term treatment. Availability of medical therapies that can be used long-term is important for this typically younger patient population.”
Taylor reports that the treatment’s improvement for constipation is of particular interest as it marks the first time a medication of this kind has effectively tackled this “common and debilitating symptom of endometriosis.”
While the treatment is still a way off from official approval and distribution, these results support the continued development of linzagolix as a potential treatment for endometriosis and its associated symptoms.