Viatris reports success in Phase 3 birth control patch study

Published 08/05/2025, 11:54
Viatris reports success in Phase 3 birth control patch study

PITTSBURGH - Viatris Inc. (NASDAQ:VTRS), a prominent pharmaceutical company with a market capitalization of $10.3 billion and currently rated as undervalued according to InvestingPro analysis, has announced the successful completion of a Phase 3 study for its investigational XULANE LO, a low-dose contraceptive patch. The study met its primary and secondary endpoints for efficacy and safety, potentially positioning the patch as a leading option in the birth control market.

The trial involved 1,272 women across the U.S., Puerto Rico, and Canada, assessing the patch’s effectiveness and safety over 13 cycles. With a Pearl Index of 4.14, the study confirmed the patch’s contraceptive efficacy. Additionally, the cumulative probability of pregnancy over the 13 cycles was calculated at 3.7%. The company maintains a strong financial health score of "GOOD" according to InvestingPro metrics, with a solid current ratio of 1.65.

Most adverse events reported were mild to moderate, and the patch demonstrated favorable cycle control with minimal unscheduled bleeding or spotting. Notably, the patch’s adhesion performance was strong, with only 1.3% of patches fully detaching during the seven-day period and less than 1% of participants experiencing severe local reactions.

Philippe Martin, Chief R&D Officer at Viatris, expressed confidence in the XULANE LO patch’s potential to meet a critical need for women seeking a low-estrogen, reversible birth control method with reliable adhesion. The company anticipates submitting a New Drug Application to the U.S. Food and Drug Administration in the latter half of 2025.

Viatris, a global healthcare company, aims to bridge the divide between generic and brand medications. It supplies medicines to roughly 1 billion patients annually and has a diverse portfolio that addresses various stages of life and health challenges.

This news is based on a press release statement from Viatris Inc. and has not been independently verified. The forward-looking statements in the press release involve risks and uncertainties, and there is no guarantee that the XULANE LO patch will receive FDA approval or achieve the anticipated market acceptance. Investors should note that Viatris offers a significant dividend yield of 5.6% and expects to report its next earnings on May 8, 2025. For detailed analysis and additional insights, access the comprehensive Pro Research Report available on InvestingPro, which covers this and 1,400+ other top US stocks.

In other recent news, Viatris Inc. has announced the successful completion of two Phase 3 studies for its pain medication MR-107A-02, which showed significant pain improvement and reduced opioid use in patients post-herniorrhaphy and bunionectomy surgeries. The company plans to submit a New Drug Application to the FDA by the end of 2025. Viatris has also reached a settlement framework to resolve opioid-related claims in the U.S., agreeing to pay up to $335 million over nine years. Additionally, Viatris has submitted applications to Japan’s Ministry of Health, Labor and Welfare for the approval of Effexor SR Capsules to treat generalized anxiety disorder, marking a significant development as there are currently no approved treatments for GAD in Japan. In other corporate news, Viatris has appointed Frank D’Amelio and Michael Severino to its Board of Directors, while Rajiv Malik and Harry Korman will retire at the end of their terms in December 2025. The company has also named Hemanth J. Varghese as its new Chief Strategy Officer, bringing his extensive expertise in strategy and operations to the executive team. These developments reflect Viatris’ ongoing efforts to expand its portfolio and strengthen its leadership as it continues to provide high-quality medicines to patients worldwide.

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