In the more than 25 years since Viagra’s little blue pill hit the market and the two decades that Cialis has been available, erectile dysfunction has been one the most lucrative areas of medicine. Since the two went generic in 2016 (Viagra) and 2018 (Cialis), direct-to-consumer health companies have been in an ED innovation arms race, with novel delivery forms like chews and gummies making them even easier to integrate into men’s daily life.
Though men’s sexual dysfunction is essentially on lock, for women it remains poorly understood, undertreated, and rarely mentioned. Yet, Cleveland Clinic estimates that sexual dysfunction impacts 43% of women—compared with 31% of men.
Sexual health startup Hello Cake—which already offers dissolving tablets for ED—found demand for products focused on women. “We surveyed our customers and seven out of 10 women said they needed help getting in the mood,” says Mitch Orkis, Hello Cake cofounder and CMO.
To meet that demand, the company is introducing two new prescription medications: dissolvable tablet Libido Lift Rx, and topical O-Cream. Libido Lift Rx has three main ingredients: oxytocin, a hormone produced when experiencing physical affection; tadalafil, the active ingredient in Cialis; and L-citrulline, an amino-acid that promotes blood flow. O-cream contains topical sildenafil, the main active ingredient in Viagra, and is meant to be applied directly to the vagina.
Both medications are compounded for Hello Cake by digital pharmacy company Epiq Scripts. Patients consult with a doctor via Hello Cake to make sure the medication is a good fit and that they get the right dose. The company says Libido Lift Rx works within 30 minutes, lasts for up to 72 hours, and can be taken daily. It costs $54 for six pills. O-Cream also costs $54 for six doses, can be used up to twice a day, takes about 10 minutes to work and can last for about 20 minutes, according to Hello Cake.
Hello Cake developed the products with the help of Dr. Paige Kuhlmann, who joined the effort during her medical fellowship in urogynecology and reconstructive pelvic surgery at UT Southwestern Medical Center in Dallas.
“These are things I’d prescribe to a woman individually, so the question became why not formulate all three for convenience?” Kuhlmann says. Though Hello Cake has not run its own trials on this combination, and compounded medications are not regulated by the FDA, they are made to order on a doctor’s prescription from ingredients that have been tested. “We work with doctors and pharmacy networks to make sure that the compounds are safe,” Kuhlmann says.
So far, Hello Cake’s Orkis says at least 250 customers have purchased the Libido Lift Rx prelaunch. None have reported adverse effects.
Neither oxytocin, not tadalafil or sildenafil are cleared to treat sexual dysfunction in women. However, women’s sexual dysfunction has such limited options that at times doctors do prescribe off-label treatments for it. There are several causes for sexual dysfunction in women—from physical changes due to menopause to past trauma or relationship issues. These can be treated with hormone therapy, sex therapy, and physical therapy. Yet, a high fraction of women suffer from low libido that is not due to physical or mental issues and as of yet, there are very few pharmaceutical treatments for them. “We don’t have great options,” says Dr. Monica Christmas, associate professor of obstetrics and gynecology and director of the Center of Women’s Integrated Health at University of Chicago Medicine.
Currently, premenopausal women suffering from low libido can choose between Addyi and Vylessi. Addyi is a daily pill with side effects such as hypertension, dizziness, and nausea—in addition, patients can’t drink while taking it. Vylessi is an injection that has to be taken about 45 minutes before sex, and has the same side effects and restrictions as Addyi.
“I read through the side effects and often patients say, ‘I’d rather deal with the sexual dysfunction,’” Christmas says. She noted that while she’s heard of doctors prescribing tadalafil and sildenafil for women off-label, clinical trials have failed to show improvement. Doctors who do prescribe these medications off-label often test it in the office first and monitor patients’ blood pressure for half an hour. “I don’t prescribe it myself,” Christmas said. “More research is needed to show efficacy and safety in women.”
While she will prescribe testosterone off-label, she’s never prescribed oxytocin for women’s sexual dysfunction, which the FDA cleared to treat contractions, as well as bleeding, during childbirth. With regard to compounding both in a drug, Christmas says, “Show me the FDA approval, or at least good quality data, and I’d gladly prescribe them to patients,” she says. “Until then, no.”
Yet, the reality for many women struggling with sexual dysfunction is that the choices are few and far between, and Hello Cake sees itself as stepping up to fill a hole in the market that major pharmaceutical companies aren’t playing in. “It’s $54 for six,” Orkis says. “Try one and see if it works. If you don’t like it, don’t take it.”