RALEIGH, N.C., June 2, 2023 /PRNewswire/ -- Sprout Pharmaceuticals, Inc. a pharmaceutical company specializing in women's sexual health today announced publication of abstract 12015 by the American Society of Clinical Oncology (ASCO). The abstract reporting positive interim results for the use of Addyi (flibanserin) tablets in breast cancer patients with low libido has been accepted for presentation in a Poster Discussion Session at the ASCO 2023 Annual Meeting being held virtually and in Chicago, IL from June 2-6, 2023.
Sprout`s female libido drug Addyi back in FDA crosshairs
Searchlight Pharma is pleased to confirm the commercial availability in Canada of Addyi® (flibanserin) for the treatment of Hypoactive Sexual Desire Disorder (HSDD).
Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely
Of course, everyone knows that when you break your leg you go to the emergency room. If you have a bacterial infection, you’re usually prescribed antibiotics. There’s even medication for mental health issues like depression and anxiety. But what are you supposed to do when you have a low sex drive?
Valeant, now Bausch Health, paid $1 billon in 2015 for Sprout Pharmaceuticals’ female libido drug Addyi, only to sell it back in 2017. Now as the drug is still nowhere near the blockbuster status Valeant once touted, a rival has arrived.
Following the completion of postmarketing studies for Sprout Pharmaceuticals’ Addyi (flibanserin), which is used to treat decreased sexual desire in women, the US Food and Drug Administration (FDA) has changed the labeling for the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely.
When the controversial first drug for low sexual desire in women was finally granted approval in 2015, critics accused the FDA of bowing to pressure from advocates by sanctioning the use of a drug that was found to be marginally effective in clinical trials, and dangerous when taken with alcohol. On Thursday, the agency rebuked the maker of the drug, Addyi, by refusing to entertain the company’s quest to discard the black box warning carried by the treatment, but agreed to dampen the strong warning on the basis of postmarketing data.
The U.S. Food and Drug Administration today issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the drug. The changes are the result of the FDA's review of postmarketing studies, including one required of Sprout when Addyi was approved in August 2015, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, as well as other data.
Earlier this month the makers of, Addyi—the beleaguered drug many have misguidedly labeled the “female Viagra,”—announced that the little pink pill is relaunching after years of controversy, a dramatic billion-dollar buyout and a tenacious fight from the woman behind the pill, Cindy Eckert.