Ovoca Bio’s “Female Viagra” nasal spray gets closer to the market

Called “female Viagra” in the media, Organic OvocaBP-101 (Libicore) nasal spray treatment for low libido in premenopausal women is ongoing Phase II trials in Australia and New Zealand, and is under review by the Russian Ministry of Health after successful Phase III trials there. A decision on approval in Russia is expected later this year.

BP-101 is designed for premenopausal women who have hypoactive sexual desire disorder (HSDD) – extremely low libido.

“About 4 million women seeking treatment in the United States, with similar prevalence estimates in Europe,” Christopher Wiltshire, sales manager at Ovoca Bio, told BioSpace, via email.

If approved, it will be available by prescription in most major markets.

According to the FDA, “HSDD is characterized by low sexual desire which causes marked distress or interpersonal difficulties and is not due to a coexisting medical or psychiatric problem, problems in the relationship or the effects of a drug. or another drug substance “.

Unlike Viagra (sildenafil), which treats erectile dysfunction in men by relaxing the muscles in the walls of blood vessels to increase blood flow, BP-101 works in women by increasing sexual desire.

“BP-101 is a new synthetic peptide that has been shown in clinical trials to be effective in the treatment of HSDD,” said Wiltshire. “It is administered by a nasal spray and delivers the active ingredient to the olfactory and trigeminal nerves in the nasal cavity, where the drug accumulates in the olfactory bulb and (transmits) further into 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 treatment is) sufficiently protected in the patent filings,” Wiltshire said.

Susan Davis, director of the Women’s Health Research Program at Monash University in Australia and researcher in this study, shed light on her activity during a interview on Australian 9News last February, just after the registration of the first patient in this trial.

“This molecule works in central brain pathways – particularly in the GABA pathway – that influence sexual behavior,” she said.

This interaction increases sexual thoughts and sexual interest.

The Oceania trial is “a Phase II assay study evaluating BP-101 at 13 sites in Australia and New Zealand,” Wiltshire said.

The randomized, double-blind, placebo-controlled study provides for a total enrollment of 476 premenopausal women randomized between the ages of 21 and 50. If this trial is successful, it will support a clinical program in the US and the EU.

HSDD is a bigger problem than many doctors realize. In one Study 2020 reported in Fertility and sterility, Davis studied 7,000 Australian women aged 18 to 39. She found that 50% expressed problems regarding sex and 20% experienced dysfunction – mainly a poor sexual self-image.

“The proportions of women with impaired self-image, arousal, desire, orgasm, and responsiveness were 11.1%, 9%, 8%, 7.9%, and respectively. 3.4%, “wrote Davis and colleagues.

An earlier US study, the 1992 National Survey of Health and Social Life, found that sexual complaints were common and were reported by up to 43% of women surveyed.

Despite decades of data, female sexual dysfunction is often not taken seriously. As Wiltshire pointed out, “This has unfortunately resulted in a lack of R&D activity in the region. Fortunately, we are seeing increased interest in investing in women’s health and hopefully BP101 can be part of that change.

The United States Food & Drug Administration (FDA) considers HSDD a high priority because there is a significant unmet medical need.

The phase III trial which ended in 2019 in Russia “showed that BP-101 proven effectiveness without safety concerns in premenopausal women with HSDD. The data were clinically and statistically significant and patients reported a significant increase in the number of satisfying sexual events compared to the placebo group, as well as a significant improvement in sexual desire and a reduction in distress associated with low sexual desire ” Wiltshire said. .

Specifically, compared to placebo, the women in this trial reported an increase in the number of satisfying sexual events, as well as an average improvement of 1.14 points in scores on the Female Sexual Function Index: desire, 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 Australian and New Zealand study are not available.

“The results of the ongoing Phase II study (in Australia and New Zealand) will be published once the trial is completed next year,” Wiltshire said.

As Ovoca completes this study, it is preparing for marketing authorization in Russia.

“We are also working on the development of a new manufacturing process and a new source in Western Europe and we are preparing for long-term toxicology studies to facilitate the next phase of our international clinical development program,” said Wiltshire .


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