A new drug with the potential to treat pain associated with endometriosis is getting closer to official approval.
With no known cause or cure, many patients have run out of options and are living with chronic and constant symptoms.
It is desperately needed that safe and effective long-term treatments that can help patients live pain-free lives are available, and yet to date very few drugs have been approved for clinical use.
Elagolix and leuprorelin can't be taken for more than two years because of adverse effects.
These drugs can cause irreversible loss of bone density, and can also cause menopausal-like symptoms, such as hot flushes, insomnia, and mood changes.
One day, an experimental drug in the same class, called linzagolix, could prove to be a better alternative. It is being tested by ObsEva as a potential way to treat pain from endometriosis and heavy menstrual bleeding from uterus.
The FDA reviewed linzagolix as a treatment for uterine fibroids after the results of two phase 3 clinical trials.
It might not be long before the drug is considered a treatment for people with the condition.
ObsEva recently announced topline results when using linzagolix to treat women with moderate-to-severe endometriosis-associated pain. The findings from the phase 3 clinical trial need to be taken with a grain of salt because they haven't been peer-reviewed. Hopefully, we'll have more details soon.
There were two different daily linzagolix doses tested in the trial.
The higher dose of linzagolix gave patients an "add-back" hormonal therapy, as it works on the brain to reduce estrogen production in the ovaries.
Endometriosis occurs when tissue similar to the uterus grows elsewhere in the body, where it responds to hormones, including estrogen, as it would on the inside of the uterus.
This can be associated with a lot of pain.
After three months, both doses of linzagolix resulted in a significant reduction in severe and frequent menstrual pain, as well as menstrual-related constipation.
Improvements continued for six months. Side effects were limited.
About 20% of people on the low dose and half of those on the high dose had hot flushes during the phase 2b clinical trials.
The low-dose linzagolix showed no clinically significant impact on bone mineral density, while the high-dose only showed minimal loss.
There is still a critical need for therapeutic options for women who suffer from this chronic condition despite recent advances in non- surgical treatment.
The dose of linzagolix demonstrated excellent efficacy along with minimal changes in bone mineral density, suggesting it may be used for long-term treatment.
Researchers at ObsEva say the low dose is being tested as an option for patients who cannot or do not wish to take hormones with add-back therapy.
Adding-back hormonal therapy is not included in the higher dose option of linzagolix.
The drug may not appeal to everyone with endometriosis, but it is promising that drug researchers and pharmaceutical companies have finally begun to take gynecological pain seriously. The more treatment choices we can give people with diseases, the better chance they have of finding a cure.
