An ongoing trial conducted by Sprout Pharmaceuticals, a Raleigh-based firm, has yielded interim results indicating that their drug, often referred to as “female Viagra,” can be used safely and effectively in women with breast cancer who suffer from low sexual desire. This finding comes as a potential breakthrough for Sprout, which gained FDA approval in 2015 but failed to meet the expected financial success that led to the company’s $1 billion sale that same year. Subsequently, CEO Cindy Eckert and other shareholders repurchased Sprout from Valeant Pharmaceuticals, as the drug did not live up to the initial sales projections, as reported by FiercePharma in 2017.
Sprout, which recently secured over $7 million in new funding, announced the study results on Friday regarding its product Addyi, colloquially known as the “little pink pill.” Addyi is recognized as the first and only FDA-approved non-hormonal pill designed for premenopausal women diagnosed with acquired, generalized hypoactive (low) sexual desire disorder.
The breast cancer-related study’s findings were initially presented at the Annual Meeting for The International Society for the Study of Women’s Sexual Health in 2022. The study abstract will be made available at the American Society of Clinical Oncology meeting in Chicago, which commenced today. Dr. Shari Goldfarb, a breast medical oncologist from Memorial Sloan Kettering Cancer Center, serves as the primary investigator for the study.
Dr. Goldfarb emphasized the prevalence of decreased libido as an undertreated and distressing symptom among women with breast cancer undergoing endocrine therapy. The study aimed to address this issue by evaluating the impact of flibanserin, the active ingredient in Addyi, on decreased libido in this patient population. The results indicate that flibanserin can be safely and effectively used in women with breast cancer, leading to statistically significant improvements not only in libido but also in other relevant areas.
Dr. Goldfarb stated, “Flibanserin should be offered to women with breast cancer experiencing bothersome and medication-induced decreased libido. Having a medication to address this often overlooked issue will enhance the quality of life and sexual function of millions of women with breast cancer.”
The trial, conducted at Memorial Sloan Kettering Cancer Center, aims to enroll 43 women. Sprout outlined the primary endpoint of the study as evaluating the feasibility of administering flibanserin 100 mg orally at bedtime for 24 weeks in women with breast cancer undergoing endocrine therapy.
According to Sprout, approximately 70% of women diagnosed with breast cancer report experiencing sexual dysfunction.
CEO Cindy Eckert referred to the interim results as an “important step” for the company.
For more information about the trial, please visit: https://clinicaltrials.gov/ct2/show/record/NCT03707340.
Other trials conducted by Sprout have also provided supporting evidence for the efficacy of Addyi. In 2020, data from three clinical trials presented by the company demonstrated significant improvements in female sexual dysfunction related to arousal, desire, lubrication, satisfaction, and orgasm.
It is worth noting that Sprout encountered difficulties with the US Food and Drug Administration in 2019. This occurred after the company issued a press release regarding the potential for less restrictive labeling for the use of Addyi with alcohol. The press release was subsequently removed from the Sprout website.
In 2015, pharmaceutical giant Valeant purchased Sprout for $1 billion but later sold it back to Eckert and other shareholders in exchange for product royalties.