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Contraceptive developers eschew hormones in pursuit of new products for women

Sixty years after the FDA approved the hormonal contraceptive pill, companies are still struggling to develop and successfully market nonhormonal alternatives.

Though the contraceptives market is large — placed at $18.4 billion in 2016 by Grand View Research — noticeable gaps in birth control products available to women remain. Long-acting contraceptive options include hormonal products such as progestin intrauterine devices, or IUDs; implants in the upper arm; and three-month injections, as well as nonhormonal copper IUDs. Birth control pills; hormonal patches and vaginal rings; and nonhormonal, on-demand male condoms are shorter-term products that allow the user to stop use at any time.

Hormonal oral contraceptives have one of the highest efficacy rates — 91%, according to the Centers for Disease Control and Prevention — but some women choose not to take them or simply cannot due to cancer, breastfeeding, pre-existing diabetes or cardiovascular diseases, or high body mass index. Hormonal contraceptives also commonly come with side effects, from bloating and acne to nausea and vaginal infections. Since as early as 1981, studies have shown a correlation and possible causality between oral contraceptives and depression.

Birth control products like the daily pill have been on the market for so long that female consumers are familiar with and even accustomed to the extensive list of possible effects.

"[Side effects] are just expected," Saundra Pelletier, CEO of women's health company Evofem Biosciences Inc., said. "Women adjust their bodies every day to a synthetic hormone, even if they don't have sex every day."

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Past attempts and successes

Fueled by the drawbacks of existing contraceptive options, some companies have made efforts to fulfill unmet needs and offer alternatives. Successfully introducing a new product, however, has proven difficult for both long- and short-acting products — especially as novel birth control options could come with equally new and unfamiliar side effects.

Bayer AG's nonhormonal birth control device Essure was approved by the U.S. Food and Drug Administration in 2002 as a permanent implant, but the company has since halted U.S. sales following reports of side effects, safety issues and removal difficulties. The controversy was renewed with the April premiere of the Netflix medical device documentary The Bleeding Edge, which said side effects of the device can persist five to 15 years after insertion. Essure is the only contraceptive implant that does not require a surgical incision.

In 2014, University of Southern California master's student Laura Sech completed a study on using cilostazol, typically used to treat peripheral artery disease, to block pregnancy. Sech eventually concluded that the data was "not clinically relevant," as oocyte maturation was not impaired in humans with the FDA-approved dosage. Sech wrote that a higher dosage would pose "potential for toxicity." No follow-up has been conducted.

One nonhormonal option available is the Caya diaphragm, which was launched in the U.S. in 2015. PATH, a global innovation lab that specializes in healthcare technologies and drug development, began working on the Caya in 1994 alongside CONRAD, a non-profit reproductive health researcher. The product's launch was facilitated in the U.S. by HPSRx, a women's health distribution company. As a multiprevention technology product, or MPT, the Caya provides cervical protection and prevention of some bacterial sexually transmitted infections when combined with a microbicide gel. Unlike traditional diaphragms, the Caya fits most women, and free tests are provided if it does not.

But the product struggled to catch on. HPSRx co-founder Bob Patane said in a 2015 The Atlantic article that the distributor had difficulties making the Caya accessible to consumers.

Operations manager Patti Keith said in an interview that she has since seen improvement. The Caya is now available in most pharmacies and covered by most insurance plans, but the U.S. still requires a prescription to obtain the product.

"I personally don't understand why," she said, adding that some physicians simply do not like diaphragms.

Keith also acknowledged that getting the Caya to customers continues to pose challenges, as some pharmacies tell women they do not carry the Caya diaphragm even when they do due to the historical lack of availability.

Ongoing efforts

Daré Bioscience Inc. and Evofem are individually developing prescription nonhormonal options in other product categories.

Daré Bioscience's nonhormonal ring Ovaprene is expected to conclude a postcoital test clinical trial in the second half of 2019. Ovaprene works as a barrier with a spermicide-like environment and is taken out monthly when the menstrual cycle occurs. It will likely have the same rate of effectiveness as a diaphragm, Daré Bioscience Chief Business Officer John Fair said.

Evofem's Pelletier said the company's MPT contraceptive Amphora will conclude a phase 3 clinical trial in early 2019 and launch in early 2020 if successful. The pH-balancing gel is also being reviewed by the FDA to treat chlamydia, and Evofem is exploring its possible use to treat bacterial vaginosis, a common infection characterized by a buildup of bacteria in the vagina. Both the recurrence of bacterial vaginosis, which has a rate of 60%, and chlamydia have no treatments.

More options, more control

Both Daré and Evofem cited control over one's own body as an area of unmet need in existing contraceptives.

"Half of all women say, I don't want something [like an IUD] that I can't control," Pelletier said. "I don't want to think that I have to go to a doctor to have that taken out. I want to control my own body and what goes in it."

PATH Director Patricia Coffey said a male condom is not a contraceptive women can control, either.

"Some men say they don't like the feeling, that it's not comfortable," Coffey said. "Men might not want to take the initiative every time they have sex."

According to Coffey, encouraging healthy sexual behavior involves the availability of other options, such as products that give women more initiative.

"If you look at women's usage patterns over time, they're trying to find the right solution for them, given their life stage, their values at the time, so there is never going to be a 'one size fits all' solution for women," Fair said. "They're going to need different options for different times of their lives, whether that's long-acting or something more actively monitored."

Pelletier also pointed out increasing emphasis on healthy lifestyles, as well as social movements like Time's Up and Me Too.

"We don't have hormones in our milk, we don't have hormones in our food, we're paraben-free," she said. "We recognize and wonder, what are these different chemicals doing to our body? So there's been an evolution in the mindset of women."

Women-led women's health

Women's health companies have been on the rise in recent years, with increased awareness and focus on uterine pain, female sexual dysfunction and cervical health. Some of the challenges along the way, Pelletier said, have stemmed from a lack of women in healthcare.

Fair said the main challenge in women's health is "on the other side" where investors sit, citing complacency as an issue.

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Saundra Pelletier, CEO of Evofem
Source: Evofem Biosciences

Studies by executive search firm Liftstream in 2017 showed that women held 10.9% of board seats at 177 surveyed biotech companies, while 98% of the companies' boards were headed by a male chairman. Researchers at Babson and Wellesley colleges found that from 2011 to 2013, female CEOs received 3% of venture capital funding across 7,000 companies. As of December 2016, a majority of the top 72 venture capital firms were led by males, with 89% of the decision-makers being men, according to venture capital firm The Information and Social Capital.

"There haven't been enough people talking to these investors and suggesting to them: 'Talk to your wife, your girlfriend or fiancée, your daughter,'" Pelletier said.

In the meantime, Pelletier said she intends to continue working on how she talks about these issues to help people listen and close the gap in understanding.

"There are a lot of misperceptions around reproductive anatomy, sex and family planning methods," PATH's Coffey said.

Nevertheless, Fair said he anticipates an expanding contraceptive market and that women's health companies like Daré stand on the shoulders of others' successes. Both Pelletier and Fair said women as consumers are ready for new contraceptives, especially nonhormonal ones.

"There's already an interested and invested consumer at the other end of the message," Fair said. "When you can raise awareness around an issue that she's been dealing with for months or years or decades, that's going to resonate, and women are making a lot of the financial purchases in the house, particularly in healthcare."