Elagolix, The first oral drug Elagolix showed promising results in the treatment of three types of pain in endometriosis reports the results of a study presented at the annual clinical and scientific meeting of the annual American College of Obstetricians and Gynecologists at Austin, Texas.
Elagolix, is a gonadotropin-releasing hormone (GnRH) receptor antagonist manufactured by AbbVie, a global research and development-based biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc.
“There have been no new medications approved for a long time for systematic endometriosis and there is a huge gap because the current options are expensive, and they are often injectable drugs,” said presenter Dr. Surrey.
In this extension of an earlier phase3 trial, women with moderate to severe endometriosis-related pain who participated in the initial randomized, placebo-controlled trial were given either a 150- or 200-mg dose of Elagolix (NCT01620528).
About 569 women from 149 locations continued the treatment during the extension phase of 12 months to study the safety and efficacy of Elagolix over prolong period.
The average age of each patient group was between 31 and 34 years, and all groups were majority white, with a mean length of time from surgical diagnosis ranging from 45.5 to 56.6 months.
Patients reported a decrease in daily analgesic use by 46%-77% and improvement in dysmenorrhea and chronic pelvic pain by 49%-53% with 150 mg dose and by 82% for those at 200 mg.
Common side effect reported during the extension period was hot flashes, but they were not as severe as GnRH analogs and did not require any additional treatment. GnRH analogs are current gold standard for endometriosis and cause severe hot flashes requiring additional treatment.
The drug is also being evaluated in the treatment of uterine fibroids.
FDA is already on Elagolix and has announced April 2018 that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for Elagolix in endometriosis-associated pain.
" We are pleased with the outcomes of the pivotal trials thus far. AbbVie will continue to pursue Elagolix as a potential new treatment for the disease's most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle," said Michael Severino, the chief scientific officer at AbbVie, at the time.
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