A new drug, linzagolix, which is seen as a potential treatment for endometriosis-linked pain with few adverse side effects, is inching closer and closer to becoming officially approved after demonstrating promising results in its Phase 3 trials.
Understanding Endometriosis
According to Mayo Clinic, Endometriosis is a painful disorder where tissue similar to the type of tissue that usually lines the interior of the uterus grows outside the organ. It most commonly involves women's fallopian tubes, ovaries, and tissues that line the pelvis. Rarely, endometrial-like tissues can also be found beyond the pelvic organ.
The tissue in a person diagnosed with endometriosis thickens, breaks down and bleeds with each menstrual cycle. However, since the tissue has no existing way of exiting the body, it becomes trapped. It is known as endometriomas form when it involves the ovaries and cysts. Surrounding tissues then become irritated and eventually develop scar tissues and adhesions.
Common symptoms of endometriosis include painful periods, pain during intercourse, pain during urination and bowel movements, excessive bleeding, infertility, and more.
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Promising Phase 3 Trial Results for Endometriosis-Associated Pain
Effective long-term treatments that help patients diagnosed with endometriosis live pain-free lives are desperately sought out, yet few drugs have been approved for clinical use. For now, approved drugs such as leuprorelin and elagolix aren't effective for everyone and cannot be taken directly over two years due to severe side effects. Drugs such as these not only lead to significant irreversible loss of bone density but can also induce menopausal-like symptoms such as insomnia, mood changes, hot flushes, and more.
However, an experimental drug of the same class known as linzagolix is currently being tested by ObsEva, a biopharmaceutical company, as a potential treatment for endometriosis-associated pain and heavy menstrual bleeding from uterine fibroids.
By the end of 2021, phase 3 clinical trials showed promising results, enough to convince the US Federal Drug Advisory to review the new drug as a treatment for uterine fibroids. With the drug's current trajectory, it's easy to see how official approval is on the horizon, and pain-free life for people with endometriosis could soon be achieved.
ObsEva recently announced the use of the drug to treat women with moderate to severe pain linked with endometriosis. However, findings from the phase 3 trials have not been peer-reviewed; hence, they should be taken with a grain of salt. On the other hand, preliminary results are promising, and many hope to receive more details in the near future.
For now, there are two doses of linzagolix being tested, a lowered dose for moderate pain and a higher dose that will be coupled with an "add-back" hormonal therapy. The company behind the new drug is looking into developing a higher dose option that will no longer include hormonal therapy, reports ScienceAlert.
Although the new drug may not appeal to everyone diagnosed with endometriosis, it is promising that pharmaceutical companies and researchers are finally beginning to seriously face gynecological pain. More treatment choices for people with incurable conditions offer a more inclusive treatment for everyone.
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