Viatris Announces Positive Results from Phase 3 Study of Investigational XULANE LO™ Low Dose Patch for Birth Control in Women of Childbearing Potential
Viatris (NASDAQ: VTRS) announced positive Phase 3 study results for its investigational XULANE LO™ low dose contraceptive patch. The study, involving 1,272 women across 81 sites in the U.S., Puerto Rico, and Canada, demonstrated favorable efficacy with a Pearl Index of 4.14 and a 3.7% cumulative pregnancy probability over 13 cycles.
The patch showed strong performance metrics, including excellent adhesion with only 1.3% of patches completely detaching during the seven-day wearing period and less than 1% of subjects reporting severe local application site reactions. Most treatment emergent adverse events were mild-to-moderate, with favorable cycle control and low unscheduled bleeding events. Viatris plans to submit a New Drug Application to the FDA in the second half of 2025.
Viatris (NASDAQ: VTRS) ha annunciato risultati positivi dello studio di Fase 3 per il suo cerotto contraccettivo a basso dosaggio sperimentale XULANE LO™. Lo studio, che ha coinvolto 1.272 donne in 81 centri negli Stati Uniti, a Porto Rico e in Canada, ha mostrato un'efficacia favorevole con un Indice di Pearl di 4,14 e una probabilità cumulativa di gravidanza del 3,7% su 13 cicli.
Il cerotto ha evidenziato ottime prestazioni, inclusa un’adesione eccellente con solo il 1,3% dei cerotti completamente staccati durante il periodo di utilizzo di sette giorni e meno dell’1% delle partecipanti che ha riportato reazioni locali gravi nel sito di applicazione. La maggior parte degli eventi avversi emergenti dal trattamento è stata da lieve a moderata, con un buon controllo del ciclo e pochi episodi di sanguinamento non programmato. Viatris prevede di presentare una Domanda di Nuovo Farmaco alla FDA nella seconda metà del 2025.
Viatris (NASDAQ: VTRS) anunció resultados positivos del estudio de Fase 3 para su parche anticonceptivo de baja dosis experimental XULANE LO™. El estudio, que involucró a 1,272 mujeres en 81 sitios en EE. UU., Puerto Rico y Canadá, demostró una eficacia favorable con un Índice de Pearl de 4.14 y una probabilidad acumulada de embarazo del 3.7% durante 13 ciclos.
El parche mostró métricas sólidas de desempeño, incluida una adhesión excelente con solo el 1.3% de los parches que se desprendieron completamente durante el período de uso de siete días y menos del 1% de las participantes que reportaron reacciones severas en el sitio de aplicación. La mayoría de los eventos adversos emergentes del tratamiento fueron leves a moderados, con un control favorable del ciclo y pocos episodios de sangrado no programado. Viatris planea presentar una Solicitud de Nuevo Medicamento a la FDA en la segunda mitad de 2025.
Viatris (NASDAQ: VTRS)는 실험용 저용량 피임 패치 XULANE LO™의 3상 임상시험에서 긍정적인 결과를 발표했습니다. 미국, 푸에르토리코, 캐나다 81개 사이트에서 1,272명의 여성을 대상으로 진행된 이번 연구는 펄 지수 4.14와 13주기 동안 누적 임신 확률 3.7%라는 우수한 효능을 입증했습니다.
이 패치는 7일 착용 기간 동안 1.3%의 패치만 완전히 떨어지는 뛰어난 접착력과 1% 미만의 대상자가 심각한 국소 부작용을 보고하는 등 강력한 성능 지표를 보였습니다. 대부분의 치료 관련 이상 반응은 경증에서 중등도였으며, 주기 조절이 우수하고 계획되지 않은 출혈이 적었습니다. Viatris는 2025년 하반기에 FDA에 신약 신청서를 제출할 계획입니다.
Viatris (NASDAQ : VTRS) a annoncé des résultats positifs d’une étude de phase 3 pour son patch contraceptif expérimental à faible dose XULANE LO™. L’étude, menée auprès de 1 272 femmes réparties dans 81 centres aux États-Unis, à Porto Rico et au Canada, a démontré une efficacité favorable avec un indice de Pearl de 4,14 et une probabilité cumulative de grossesse de 3,7 % sur 13 cycles.
Le patch a présenté d’excellentes performances, notamment une adhérence remarquable avec seulement 1,3 % des patchs se détachant complètement durant la période de port de sept jours et moins de 1 % des sujets rapportant des réactions locales sévères au site d’application. La plupart des événements indésirables liés au traitement étaient légers à modérés, avec un bon contrôle du cycle et peu de saignements non programmés. Viatris prévoit de soumettre une dossier de demande de nouveau médicament à la FDA dans la seconde moitié de 2025.
Viatris (NASDAQ: VTRS) gab positive Ergebnisse der Phase-3-Studie für sein experimentelles niedrig dosiertes Verhütungspflaster XULANE LO™ bekannt. Die Studie, an der 1.272 Frauen an 81 Standorten in den USA, Puerto Rico und Kanada teilnahmen, zeigte eine günstige Wirksamkeit mit einem Pearl-Index von 4,14 und einer kumulativen Schwangerschaftswahrscheinlichkeit von 3,7 % über 13 Zyklen.
Das Pflaster zeigte starke Leistungswerte, darunter eine hervorragende Haftung, da nur 1,3 % der Pflaster während der siebentägigen Tragezeit vollständig abfielen, und weniger als 1 % der Teilnehmerinnen berichteten von schweren lokalen Reaktionen an der Anwendungsstelle. Die meisten behandlungsbedingten Nebenwirkungen waren leicht bis mäßig, mit guter Zykluskontrolle und wenigen ungeplanten Blutungen. Viatris plant, in der zweiten Hälfte des Jahres 2025 einen Neuartigen Arzneimittelantrag bei der FDA einzureichen.
- Achieved primary and all secondary efficacy endpoints in Phase 3 trial
- Demonstrated favorable safety profile with mostly mild-to-moderate side effects
- Excellent patch adhesion with only 1.3% complete detachment rate
- Low rate (<1%) of severe local application site reactions
- FDA submission planned for H2 2025, advancing commercialization timeline
- Pearl Index of 4.14 indicates some pregnancy risk remains
- 3.7% cumulative probability of pregnancy over 13 cycles
Insights
Viatris's XULANE LO contraceptive patch achieved all Phase 3 endpoints with strong adhesion performance, advancing toward FDA submission in 2025.
The Phase 3 study results for Viatris's investigational XULANE LO contraceptive patch demonstrate significant clinical promise. The trial's robust design included 1,272 women across 81 sites, generating 9,105 efficacy evaluable cycles - providing substantial statistical power for regulatory consideration.
The demonstrated Pearl Index of 4.14 and 3.7% cumulative pregnancy probability over 13 cycles indicate effective contraception, particularly for a transdermal delivery system. For context, a Pearl Index of 4.14 means approximately 4 pregnancies per 100 woman-years of use, which is competitive for a patch formulation.
Most impressive is the patch's physical performance characteristics. The 1.3% complete detachment rate represents exceptional adhesion that addresses a primary historical limitation of contraceptive patches. Similarly notable is the less than 1% rate of severe application site reactions, indicating excellent dermal tolerability.
The favorable cycle control with minimal unscheduled bleeding demonstrates that the reduced hormone levels (specifically the 17.5 mcg ethinyl estradiol) maintain effective endometrial stability while potentially reducing estrogen-related side effects.
With New Drug Application submission planned for H2 2025, this represents a clear advancement in Viatris's women's health portfolio, offering a differentiated low-dose option that balances efficacy, convenience, and potential safety advantages in the hormonal contraceptive market.
Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints
Results Demonstrated Potential Best-In-Class Patch Performance
New Drug Application Submission to
In this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile. In particular:
- With a Pearl Index (PI) of 4.14, the study demonstrated contraceptive efficacy. This primary efficacy endpoint was measured in eligible women aged 16 to 35 with a body mass index <30 mg/m2 and at least one efficacy evaluable cycle. Additionally, the cumulative probability of pregnancy over 13 cycles was
3.7% . - A favorable safety and tolerability profile was observed with most treatment emergent adverse events (TEAEs) reported as mild-to-moderate. Favorable cycle control was also observed with generally low unscheduled bleeding and spotting events.
- The study demonstrated a potential best-in-class patch adhesion profile with very few patches (
1.3% ) completely detaching over the seven-day wearing period and <1% of subjects reporting severe local application site reactions.
"We are pleased with the profile our investigational XULANE LO low dose patch demonstrated in this Phase 3 study," said Viatris Chief R&D Officer Philippe Martin. "The data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance."
The Company plans to submit a New Drug Application to the
About the Phase 3 Study Design (NCT05139121)
The multicenter, open-label, single-arm study, evaluated the contraceptive efficacy of investigational XULANE LO low dose patch when used over thirteen 28-day cycles in 1,272 healthy, post-menarcheal, pre-menopausal, heterosexually active female subjects of childbearing potential who are at least 16 years of age.
About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the
Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding the outcomes of clinical trials; NDA submission to FDA anticipated in the second half of 2025; XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile; and the data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the
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SOURCE Viatris Inc.
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