Jun 18, 2024

One Step Closer to Our Larger Goal

 

FDA Approval of Novel Medication for Women

Anyone within the healthcare or pharmaceutical industry knows that clinical trials are essential for medical advancement. From novel treatments to improvements in the current standard of care, clinical research leads to better health outcomes. The goal of these trials is to one day achieve FDA approval for new care options, making them available to the public. At Circuit Clinical, our mission is to transform the experience of finding, choosing, and participating in clinical research. Specifically, we focus on easing the burden of participation in clinical trials. This focus includes providing trials where people already receive their healthcare or through remote visits that allow people to participate wherever they may be.

 

One of our key methods to improve access is to partner with health systems and private practices in communities that historically had limited access to clinical research. It is in one of these healthcare practices, located in our Western New York District, where our Team was involved in the early stages of a new treatment for vasomotor symptoms, known as hot flashes, among women experiencing peri-menopausal and menopausal symptoms. In collaboration with our clinical research experts embedded within the research sites, the physicians who have trusted relationships with their patients, and the industry-leading pharmaceutical company that sponsored the trial, we were able to enroll participants and contribute to the medical understanding of this drug. Incredibly, this new treatment reached FDA approval in May 2023, making it one of the 55 novel treatments to be approved that year (de la Torre, Albericio, 2024)1, and we are proud to play a small role in this accomplishment.

 

The new treatment, known as Veozah, is currently on the market and in the early stages of post-approval marketing—most notably featured in an ad during the 2024 NFL Super Bowl, putting women’s health center stage. While initially, the treatment had low usage, according to a report from Komodo Health, “From its market debut in 2023, Veozah prescriptions experienced a steady rise, from just under 900 in June to more than 5,000 by October.” (Komodo Health Editorial Team, 2024)2 One of the things that makes Veozah a unique treatment option, is unlike many current standard of care treatments for hot flashes, Veozah is non-hormonal. This option is an important distinction, as many women who have some cardiovascular conditions such as stroke, heart attack, blood clots, or liver disease are unable to receive hormonal replacement therapy (the current treatment standard). New medications, like Veozah, drive at the core of our mission here at Circuit—bringing new care options to all.

 

Part of the “all” includes the historical exclusion of women in research. To quote Dr. Tabby Khan, featured in an article from Pharmavoice, “Menopause symptoms have historically been overlooked,” Khan said. “There’s this general sentiment…that menopause is not a disease that needs to be treated, that it doesn’t automatically require any treatment. It’s just part of women aging and going through different phases of life.” (Pecci, 2024)3 

 

This view follows a trend in women’s healthcare: women and women-specific diseases have a low involvement in clinical research. This lack of involvement can lead to limited treatment options, a lack of current standards of care, and treatments that do not work as effectively for women. As an example, it wasn’t until 1993 that the U.S. Congress passed a law requiring the inclusion of women in clinical research; even then, in 2019, only 40% of participants were women in trials involving cancer, cardiovascular disease, and psychiatric disorders—despite making up over 50% of the U.S. population. (Balch, 2024)4 While the participation of women in more clinical studies and research focus on women-specific conditions is improving—there is more to do.  We are just starting to see a shift in this trend, and our Team intends to move the needle in the right direction.

 

We believe the needed changes in clinical research can be achieved through our partnerships in healthcare, and we know that our journey takes hard work. Our Team must go the extra mile to ensure patients feel safe, comfortable, and educated to choose research as a care option. It also requires physicians and healthcare providers to work with our research experts to understand their patient population. Furthermore, it involves research sponsors trusting us to deliver on their expectations and complete their trials so that they may one day become available on the market—expanding medicine and making a difference in the lives of others. Though Veozah is one example, we eagerly look forward to seeing many more trials our Team conducts achieve the same end goal.

 

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You can learn more about our Community-Based Research Network and read other examples of successful trials here: https://www.circuitclinical.com/solutions/site-partnership-network/ 

 

 

Sources:

  1. de la Torre, B. G., & Albericio, F. (2024). The Pharmaceutical Industry in 2023: An Analysis of FDA Drug Approvals from the Perspective of Molecules. Molecules (Basel, Switzerland), 29(3), 585. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10856271/ 

  2. Komodo Health Editorial Team. (2024, March 14). Veozah’s early journey: Analyzing uptake of the new drug for treatment of hot flashes. komodo health. https://www.komodohealth.com/perspectives/veozahs-early-journey-analyzing-uptake-of-the-new-drug-for-treatment-of-hot-flashes 

  3. Pecci, A. (2024, April 8). Next-gen menopause treatments have blockbuster potential. can women, doctors and payers be convinced?. PharmaVoice. https://www.pharmavoice.com/news/next-gen-menopause-treatments-veozah-astellas-pharma/712455/ 

  4. Balch, B. (2024, March 26). Why we know so little about women’s health. AAMC. https://www.aamc.org/news/why-we-know-so-little-about-women-s-health