AllianceRx Walgreens Pharmacy, a subsidiary of Walgreens, will be the exclusive provider of oteseconazole (Vivjoa; Mycovia Pharmaceutical Inc), the first and only approved medication to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in post-menopausal women or those who do not have reproductive potential, according to a press release.1
“Having Mycovia select us as the exclusive specialty pharmacy partner of [oteseconazole] is a testament to the thorough care and oversight of this medication provided by Walgreens specialty pharmacists,” Tracey James, RPh, chief operating officer of Walgreens specialty enterprise, said in the press release. “It’s not only how we care for the patients, but winning exclusive access to a limited distribution drug is also about how we support providers by getting their patients on therapy faster.”1
Oteseconazole is an azole antifungal used to reduce the incidence of RVVC in patients with a history of the infection, according to the prescribing data. It is not approved for those who have reproductive potential.2
About the Trials
Trial 1
Trial Name: A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (VIOLET)
ClinicalTrials.gov ID: NCT03562156
Sponsor: Mycovia Pharmaceuticals Inc.
Completion Date (Actual): August 2021
Trial 2
Trial Name: A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (VIOLET)
ClinicalTrials.gov ID: NCT03561701
Sponsor: Mycovia Pharmaceuticals Inc.
Completion Date (Actual): August 2021
The approval of the drug was based on 2 clinical trials, CL-011 (NCT03562156) and CL-o12 (NCT03561701). In the trials, investigators included healthy postmenarcheal nonpregnant women and girls aged 12 and older, according to the study authors. Patients included had a documented history of RVVC, which was defined as 3 or more episodes of VVC in the previous 12 months. Further, they needed to present with acute VVC with minimal vulvovaginal signs, including erythema, edema, and/or excoriation, and symptoms including itching, burning, and/or irritation, with a score of 3 or greater, according to the study authors.3
In both trials, all eligible individuals were treated with 3 doses of 150 mg of oral fluconazole every 72 hours. Patients with resolved symptoms at baseline in the maintenance phase received 150 mg of oral oteseconazole daily for 7 days followed by 150 mg weekly for 11 weeks or the placebo for 12 weeks, according to the study authors. Patients were followed for 36 weeks without treatment.3
The primary endpoint included percentage of patients with 1 or more culture-verified VVC episodes from baseline through week 48. Secondary endpoints included first recurrence, average percentage of individuals with 1 or more positive Candida cultures through the maintenance phase, average percentage of culture-verified recurrence through week 24, change in 36-Item Short Form Survey mental component score, and change in total survey score from screening through 48 weeks.3
In the first study, the average percent of individuals with 1 or more RVVC episodes from baseline through week 48 was 6.7% for those on oteseconazole compared with 42.8% on the placebo. Further, in the second study, the percentage of 3.9% compared with 39.4%, respectively.3
Furthermore, at the time of analysis, the time to first recurrence was not reached because less than 50% of individuals had a recurrence, according to the study authors. The mean time to recurrence for those receiving the study drug was 45.7 weeks in the first study and 47.8 weeks in the second. Patients in the oteseconazole group also had a significantly lower average percent of occurrence of 1 or more positive Candida cultures through week 48. The changes in screening were similar between both groups for mental component score and total score, according to the study authors.3
The addition of oteseconazole marks Walgreens enterprise specialty’s number of exclusive drugs among the highest for specialty pharmacies in the United States. They also exclusively distribute repotrectinib (Augtryo; Bristol Myers Squibb) for non–small cell lung cancer; afibercept (Eylea HD; Regeneron) for neovascular age-related macular degeneration, diabetic macular edema, and diabetic retinopathy; vedolizumab (Entyvio SQ; Takeda) for moderately active ulcerative colitis; and dexamethasone (Hemady; Edenbridge Pharmaceuticals) for multiple myeloma.1
References
AllianceRx Walgreens Pharmacy Selected as Exclusive Distributor of VIVJOA. News release. Walgreens Boots Alliance. March 14, 2024. Accessed March 18, 2024. https://www.walgreensbootsalliance.com/news-media/press-releases/2024/alliancerx-walgreens-pharmacy-selected-exclusive-distributor-vivjoar
Prescribing Information: oteseconazole (Vivjoa). Mycovia Pharmaceutical Inc.
Updated April 2022. Accessed March 18, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215888s000lbl.pdf
Sobel JD, Donders G, Degenhardt T, et al. Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis. NEJM Evid. 2022;1(8):EVIDoa2100055. doi:10.1056/EVIDoa2100055
