New Endometriosis Drug Sails Through Clinical Trials
Relugolix combination therapy reduces endometriosis-associated pain.
Endometriosis (en — doh — me — tree — oh — sis) is a condition that affects 10% of women around the globe, that’s approximately 176 million women worldwide.
So what exactly happens when you have endometriosis?
Endometriosis is an inflammatory condition in which the tissue that usually lines the womb, ends up growing in places where it isn’t supposed to be, such as on the ovaries, fallopian tubes, and even on the bowels. When the hormones fluctuate during the menstrual cycle, the endometrial tissue grows and then the endometrial tissue breaks down and bleeds. As the blood has nowhere to go, this causes inflammation, the formation of scar tissue, and even more pain!
Here are some of the symptoms of endometriosis:
- Pelvic pain
- Heavy bleeding
- Severe period pain that interferes with daily activities
- Fatigue
- Issues with conceiving
- Dyspareunia
Unfortunately, there is no cure for endometriosis at the moment. Endometriosis patients use pain relief medications to manage chronic pain, they may be given hormone-regulating medicines such as contraceptives, or they may have to undergo surgery whereby the endometrial tissue is removed, and in some cases, a hysterectomy may be required. There is a great demand for more treatment options for endometriosis patients.
Saying that… Sumitovant Biopharma and Myovant Sciences have developed relugolix combination therapy for the treatment of endometriosis, the combination therapy has been assessed in a clinical trial called Spirit. Relugolix has recently been used in clinical trials for prostate cancer and uterine fibroids. The phase III HERO clinical trial for men with prostate cancer had positive results, due to this, Myovant recently submitted a new drug application to the FDA. The results were also positive for the phase III Liberty trial for women with uterine fibroids.
In the phase III Spirit trial, women with endometriosis were given relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) once a day for 24 weeks. The relugolix combination therapy was able to reduce menstrual pain by 73.3% on average. Furthermore, the relugolix combination therapy was well tolerated and the patients had nominal bone mineral density loss.
“Women need and deserve treatment options beyond surgery, and these data indicate relugolix combination therapy has the potential to substantially reduce pain while improving function and activities of daily living and decreasing the proportion of women on opioids, all with a well-tolerated safety profile,” said Eric L. Brown, M.D., a practicing obstetrician-gynecologist and coordinating investigator in the SPIRIT program.
So how does this drug work?
Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist. The relugolix combination therapy works by reducing the production of ovarian estradiol. Ovarian estradiol is known to stimulate the growth of endometrial tissue.
Sumitovant Biopharma and Myovant science are conducting an extension study using the relugolix combination therapy in endometriosis patients for another 80 weeks. This extension study will help to determine the long term safety and effectiveness of relugolix combination therapy.
“We look forward to sharing the one-year data from the SPIRIT extension study and submitting a New Drug Application to the FDA for this one dose, one pill, once a day potential treatment for women with endometriosis, which would be our third NDA submission in short succession.” said Juan Camilo Arjona Ferreira, chief medical officer of Myovant Sciences.
