RALEIGH – A report about an ongoing trial of the drug from Raleigh-based Sprout Pharmaceuticals for treatment of low sexual desire in women finds in interim results that the so called ‘female Viagra’ can “be used safely and effectively in women with breast cancer.”
The study could be good news for Sprout which was approved by the FDA in 2015 but has yet to prove to be the financial boon expected that led to the $1 billion sale of the company in 2015. CEO Cindy Eckert and other Sprout shareholders later reacquired Sprout from Valeant Pharmaceuticals when the “drug has proven to be worth a tiny fraction of the sales touted upon its approval,” as FiercePharma reported in 2017.
Sprout, which raised more than $7 million in new capital in April, reported the study Friday about its Addyi [Flibanserin] product, or the “little pink pill.”
The company points out that Addyi is “the first and only FDA-approved non-hormonal pill for acquired, generalized hypoactive (low) sexual desire disorder for premenopausal women.”
Results of the breast cancer-related study were first disclosed at the Annual Meeting for The International Society for the Study of Women’s Sexual Health in 2022.
Addyi, also called the “little pink pill” and the “female Viagra.” (Sprout Pharmaceuticals photo)
The study abstract will be posted at the American Society of Clinical Oncology meeting in Chicago, which opened today.
Dr. Shari Goldfarb, a breast medical oncologist from Memorial Sloan Kettering Cancer Center, is the study’s primary investigator.
“Decreased libido is an extremely prevalent, undertreated and distressing symptom in women with breast cancer on endocrine therapy. As investigators, we wanted to conduct a study to help treat decreased libido. This study evaluated the impact of flibanserin on decreased libido in women with breast cancer on endocrine therapy and shows that Flibanserin can be used safely and effectively in women with breast cancer.”
Goldfarb added the drug resulted in “statistically significant improvement in not only libido” but other areas.
“Flibanserin should be offered to women with breast cancer with bothersome and medication-induced decreased libido,” Goldfarb added. “Having a medication to treat this often unaddressed issue will improve the quality of life and sexual function of millions of women with breast cancer.”
The study is being conducted through Memorial Sloan Kettering Cancer Center and plans to enroll 43 women.
“The primary endpoint of this study is to evaluate the feasibility of flibanserin 100 mg orally at bedtime for 24 weeks in women with breast cancer on endocrine therapy,” Sprout said in the announcement.
According to Sprout, an estimated 70% of women “diagnosed with breast cancer report having sexual disfunction.”
\CEO Eckert called the interim results an “important step.”
For more about the trial, see: https://clinicaltrials.gov/ct2/show/record/NCT03707340.
Other trials
This is not the first time Sprout has touted clinical tests as supporting Addyi.
In 2020, Sprout data from three clinical trials proves the efficacy of Addyi.
But in 2019 Sprout tangled with the US Food and Drug Administration last fall after Sprout issued a press release over the possibility of less restrictive labeling for use of Addyi with alcohol. That release was removed from the Sprout website.
In the 2020 trials, Sprout is touting evidence that it says “demonstrates significant improvements in female sexual disfunction for arousal, desire, lubrication, satisfaction and orgasm.”
Drug giant Valeant purchased Sprout for $1 billion in 2015 then later sold it back to Eckert and other Sprout shareholders in exchange for product royalties.
Sprout Pharma says data supports efficacy of Addyi, the ‘female Viagra’
