Study Shows Potential in a New Drug That Could Increase Accessibility to Medication Abortion
A recent proof-of-concept study from The New England Journal of Medicine (NEJM) found promising results for a new medication abortion drug.
While there are already established medication abortion regimens around the globe, primarily the combination of mifepristone and misoprostol, mifepristone is fairly limited and pricey, making it less accessible. NEJM’s study presents a possible alternative that could increase safe and effective abortion access worldwide.
The study tested ulipristal acetate, a drug that has a similar chemical profile to mifepristone and has already been established as safe, in addition to being widely available. Conducting a two-stage clinical study, NEJM assessed the combination of ulipristal and misoprostol in order to determine the most effective regimen.
NEJM collaborated with teams at Gynuity Health Projects and the National Autonomous University of Mexico to help design and analyze the data. The actual data collection was implemented at the outpatient clinic of a public maternal hospital affiliated with the Mexico City Health Secretariat and Inguarán Maternal & Child Hospital.
The first stage was a dose-finding study, where sixty-six participants were randomly assigned either 60 mg or 90 mg of oral ulipristal, followed by 800 μg of buccal misoprostol. Both groups resulted in similar efficacy and safety profiles, so they decided to move forward with the 60-mg ulipristal dose in an open-label study of 133 participants using the same regimen. To evaluate acceptability, participants filled out a structured questionnaire at the end of the follow-up visit.
After collecting results, the study found that pregnancy termination occurred in 129-133 (97%) of participants with the combination dose of ulipristal-misoprostol, a comparable success rate to mifepristone-misoprostol. Regarding the participants who did not have a successful pregnancy termination, one had a completion with sharp curettage, two received manual vacuum aspiration, and one underwent a repeat medication abortion with misoprostol alone.
When asked about their satisfaction with the treatment, 130 out of 133 participants (97.7%) rated it as satisfactory or very satisfactory. The pain level also received a similar rating, with 113 out of 133 participants (85%) rating it as acceptable or very acceptable. Ultimately, 121-133 of the participants (91%) said they would recommend the treatment.
On the whole, the study demonstrates ulipristal-misoprostol’s potential to be an effective option for medication abortion. If ulipristal-misoprostol does become integrated into the market, it could help create a more equitable environment for women’s reproductive health, simply by providing more accessible options. “A major problem hindering use of medication abortion is availability,” Beverly Winikoff, the lead author of the paper and president of Gynuity Health Projects, said. “Increasing the number of methods and arsenal of options could have bold and transformative implications for potential users everywhere.”
