Ovoca Bio's "Female Viagra" Nasal Spray Inching Closer to Market
Called “female Viagra” in the media, Ovoca Bio’s BP-101 (Libicore) nasal spray therapy for low libidos in premenopausal women is undergoing Phase II trials in Australia and New Zealand, and is being reviewed by the Russian Ministry of Health after successful Phase III trials in that country. A decision regarding approval in Russia is expected later this year.
BP-101 is designed for premenopausal women who suffer from hypoactive sexual desire disorder (HSDD) – extremely low libidos.
“Approximately 4 million women seeking treatment in the U.S., with similar prevalence estimates in Europe,” Christopher Wiltshire, chief business officer at Ovoca Bio, told BioSpace, via email.
If it is approved, it will be available through prescription in most major markets.
According to the FDA, “HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship or the effects of a medication or other drug substance.”
Unlike Viagra (sildenafil), which treats erectile dysfunction in men by relaxing muscles in the walls of blood vessels to increase blood flow, BP-101 works in women by increasing sexual desire.
“BP-101 is a novel synthetic peptide that has been shown in clinical trials to have efficacy in the treatment of HSDD,” Wiltshire said. “It is administered through a nasal spray and delivers the active ingredient to olfactory and trigeminal nerves in the nasal cavity, where the drug accumulates in the olfactory bulb and (transmisses) further in the brain.”
Public details regarding the molecule are scarce to protect its intellectual property.
“The mechanism of action will be the subject of a journal publication once (the therapeutic is) adequately protected in patent filings,” Wiltshire said.
Susan Davis, director of the Women's Health Research Program at Australia’s Monash University and an investigator in this study, shed some light on its activity during an interview on Australia’s 9News last February, just after the first patient was enrolled in this trial.
"This molecule acts within the central brain pathways – particularly in the GABA pathway – that influence sexual behavior," she said.
That interaction increases sexual thoughts and sexual interest.
The Oceania trial is “a Phase II dose ranging study assessing BP-101 at 13 sites across Australia and New Zealand,” Wiltshire said.
The randomized double-blind placebo-controlled study anticipates a total enrollment of 476 randomized premenopausal women between ages 21and 50. If that trial is successful, it will support a clinical program in the U.S. and EU.
HSDD is a larger problem than many physicians realize. In a 2020 study reported in Fertility & Sterility, Davis studied 7,000 Australian women aged 18 to 39. She found that 50% expressed issues regarding sex, and that 20% experienced dysfunction – mainly a poor sexual self-image.
“The proportions of women with self-image, arousal, desire, orgasm, and responsiveness dysfunction were 11.1%, 9%, 8%, 7.9%, and 3.4% respectively,” Davis and colleagues wrote.
An earlier U.S. study, the 1992 National Health and Social Life Survey, found that sexual complaints were common, and were reported by as many as 43% of women surveyed.
Despite decades of data, female sexual dysfunction often isn’t taken seriously. As Wiltshire pointed out, “This has, unfortunately, led to a lack of R&D activity in the area. Fortunately, we are seeing an increased interest in investing in women’s health and we hope that BP101 can be part of that change.”
The U.S. Food & Drug Administration (FDA) considers HSDD a high priority, as there is significant unmet medical need.
The Phase III trial that concluded in 2019 in Russia “showed that BP-101 demonstrated efficacy without safety concerns in pre-menopausal women with HSDD. The data was clinically and statistically meaningful and patients reported a significant increase in the number of satisfying sexual events when compared to the placebo group, as well as a significant improvement in sexual desire, and reduction of distress associated with low sexual desire,” Wiltshire said.
Specifically, compared to placebo, women in that trial reported an increase in the number of satisfying sexual events, as well as a mean 1.14-point improvement in scores on the Female Sexual Function Index: Desire Domain, and a 1.2-point reduction in the Female Sexual Distress Scale. Each of the reported data points was considered statistically significant.
Preliminary results from the study Australia and New Zealand are not available.
“Results of the ongoing Phase II study (in Australia and New Zealand) will be published once the trial is complete next year,” Wiltshire said.
While Ovoca completes that study, it is preparing for market authorization in Russia.
“We are also working on the development of a new manufacturing process and source in Western Europe and are preparing for long term toxicology studies to facilitate the next phase of our international clinical development program,” Wiltshire said.