- The FDA has approved a new medication, Vivjoa (oteseconazole), to treat single and chronic vaginal yeast infections.
- During the trials, the medication showed an 89.7 percent efficacy rate in resolving infections for up to 50 weeks versus 57 percent in the control group.
- The medication is not intended for people who have the potential to become pregnant.
- The most commonly reported side effects with headaches and nausea.
- About 75 percent of women in the United States develop a vaginal yeast infection, leading to 1.4 million medical visits per year.
Vivjoa is the first
The FDA panel approved the drug based on phase three clinical trials with 875 patients across 11 countries. Participants in one group received Vivjoa for an initial infection and then for 50 weeks as a maintenance medication. The second group received fluconazole, a traditional treatment for yeast infections, and a placebo for 50 weeks.
Those receiving Vivjoa during the trial has significantly fewer infections. The first group receiving the Vivjoa had an 89.7 percent rate of clearing the initial infection and remaining infection-free for the remainder of the trial. In the second group, 57 percent did not have recurrent infections.
The most common side effects were headaches and nausea.
People of reproductive potential and those who are pregnant or nursing should not take this medication as it may cause fetal harm.
“It looks to be a novel drug predicated for those women with refractory recurrent yeast infections,” says Kecia Gaither MD, MPH, FACOG, Director of Perinatal Services at NYC Health. “The drug, primarily based on the recommendations should be utilized in a particular cohort of women — postmenopausal women and women who have had a hysterectomy.”
“For a limited number of women, this medication can be a gamechanger,” says G. Thomas Ruiz, MD, the lead OB/GYN at MemorialCare Orange Coast Medical Center in Fountain Valley, CA. “But it is very limited in its use; for example, postmenopausal women, those with permanent infertility, such as women who have had a tubal ligation or a hysterectomy. It might be possible to use it for women who have an IUD with no intention of removing it for at least two years. Another group might be women in their 40s who are not planning on becoming pregnant. But even then, anyone I prescribe it to might need to sign a waiver indicating they understand the risks.”
Mycovia Pharmaceuticals, Inc., the manufacturer of the prescription drug Vivjoa expects it to be available in the second quarter of 2022. It is available in tablets of 150 mg and purchased in a carton based on the chosen regimen. Prices to be announced.
It is approved for females with chronic yeast infections who are not of reproductive potential, pregnant, or nursing. The trials did not include enough females who were premenarchal, meaning individuals too young to have experienced a menstrual cycle, or over 65. Therefore there is not enough information to determine the efficacy and safety of these groups.
There are two recommended dosage regimens for Vivjoa.
The first is Vivjoa only:
- Day 1: 600 mg as a single dose
- Day 2: 450 mg as a single dose
- Beginning on day 14: 150 mg once a week for 11 weeks
The second regimen is a combination of Vivjoa and fluconazole:
- Days 1, 4, and 7: 150 mg fluconazole orally
- Days 14 – 20: 150 mg Vivjoa once daily
- Beginning on day 28: 150 mg Vivjoa once a week for 11 weeks
- Vaginal itching
- Soreness around the vagina and vulva
- Pain during sex
- Pain or burning when urinating
- Thick, clumpy, white discharge
Typically, the infection is mild, but some women develop severe conditions and can have swelling and fissures in the lining of the vagina.
Yeast infections are considered chronic or recurrent when a person develops four or more acute episodes of yeast infection within 12 months.
“In my practice, I currently treat women for recurrent yeast infections,” says Tara Scott, MD, FACOG, FAAFM, ABOIM, CNMP, medical director of integrative medicine at Summa Health System. “They are typically treated with a combination of medication and dietary changes and probiotics.”
According to the
- Avoiding douching as it can remove good bacteria from the vagina
- Do not use scented products in or around your vagina, including bubble baths, sprays, pads, or tampons
- Wear underwear with a cotton crotch
- Avoid wearing tight clothing, such as underwear, pantyhose, pants, and jeans, as they can increase body heat and moisture
- Change tampons and other period products frequently
- Change from wet bathing suits or sweaty workout clothes as soon as possible