A new drug with the potential to treat moderate to severe pain associated with endometriosis has been shown to be highly effective in a phase clinical trial 3, all with very few side effects.
Endometriosis is a chronic, inflammatory disease of the female reproductive system. It is explained by the development of uterine mucous membranes outside the uterus, thus colonizing other organs where they also react to hormones, thickening and bleeding with the menstrual cycle. The disease, the causes of which are still debated, would affect about 10% of French women of childbearing age . The latter suffer from varying degrees of pelvic pain during menstruation or sexual intercourse. In some cases, they also suffer from infertility. These symptoms naturally have a major impact on the quality of personal and professional life of those concerned.
Furthermore, to date there is no real cure for this disease . Indeed, the few options offered do not work for all women. In addition, there are many side effects, including loss of bone density, hot flashes, insomnia or mood changes. However, the situation could soon change.
An experimental drug called linzagolix might indeed present itself as a better alternative. The treatment is currently being tested by biopharmaceutical company ObsEva as a potential way to treat pain associated with endometriosis, as well as heavy menstrual bleeding from uterine fibroids.
At the end of 2021, the results of two phase 3 clinical trials proved interesting enough to convince the United States Federal Drug Advisory (FDA) to consider linzagolix as a treatment for fibroids . It may not be long before health authorities also consider it an effective treatment for women with moderate to severe pain associated with endometriosis.
In these trials, two different daily doses of Linzagolix were tested:a 200 mg dose and a 75 mg dose. With the higher dose, patients also received "add-on" hormone therapy. Indeed, linzagolix would have the side effect of reducing the production of estrogen in the ovaries. The 75 mg dose is therefore being tested as an option for people who are unable or unwilling to take add-on therapy.
Compared to a placebo, both doses of linzagolix reportedly resulted in a significant reduction in menstrual cramps , menstruation-related constipation (dyschesia) and pelvic pain after three months and up to six months.
In phase 2b clinical trials, hot flashes were the most common side effect . The latter would thus have affected 20% of the women concerned by the 75 mg dose and nearly half of those concerned by the 200 mg dose. At low doses, however, linzagolix would not have had any clinically significant impact on bone mineral density. Only a minimal loss was indeed observed for the high dose.
“Although there have been recent advances in the non-surgical treatment of endometriosis, there is still a critical need for treatment options “, underlines Hugh Taylor, of Yale University, who led the trials. "Once daily linzagolix 200mg add-on therapy demonstrated excellent efficacy as well as minimal changes in bone mineral density, suggesting that this dose can be used for long-term therapy . »
Note, however, that these results have not yet been peer-reviewed. They should therefore be taken with a grain of salt.
