Male Contraceptive Clears Latest Hurdle

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Following recent trials for a hormone-based male contraceptive, another experimental new type of contraceptive, which blocks sperm flow with a gel, has been successful in monkey trials. Vasalgel creates a semi-permeable barrier which, once injected into the vas deferens, prevents sperm from crossing and causes them to be reabsorbed by the body.

The company behind the innovative creation says a two-year trial shows the gel works and is safe in primates. There will hopefully be enough evidence to begin tests in human males within a few years. If these are successful, regulatory approval will be requested to make the gel more extensively available.

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This would be the first new type of male contraceptive to hit the market in many decades. At the moment, men have two main options of contraceptive; to wear a condom to catch the sperm, or have a sterilising operation (vasectomy) to cut or seal the two tubes that carry sperm to the penis from where they are made in the testicles.

Vasalgel has the same end effect as vasectomy, but researchers plan to make the reversal easier and with a higher success rate, should a man later decide he wants to have children. The plans will be that another injection should dissolve the semi-permeable gel barrier, making sperm fertile once again. This worked in early tests in rabbits, but the researchers have yet to prove the same in monkeys and humans.

The non-profit company researching Vasalgel, the Parsemus Foundation, has used grants and fundraising to get this far. Researcher, Professor Pacey commented: “I would imagine there is a worldwide market for a new male contraceptive, but trials in humans and more long-term safety data are required before we will know if it is a success.”

IBIS AND HRA AIM TO SWITCH THE PILL TO OTC

Ibis Reproductive Health and French-based HRA Pharma are working together to provide the research needed to submit an application to the US FDA to switch a progestin-only daily use oral contraceptive (OC) to OTC. For over a decade Ibis has worked with a broad coalition of healthcare providers, advocates and researchers in the Oral Contraceptives OTC Working group to build the evidence and make the case for the benefits of moving a birth control pill OTC.

Ibis highlights that too many people in the US face barriers to accessing the birth control they want and that a safe and effective OC would help people overcome some of those barriers. The coalition is committed to conducting the research and advocacy to ensure any OTC method is covered by health insurance and available to everyone who needs it.

HRA Pharma has already seen success in Rx-to-OTC switch in the EU, with its application to the European Medicines Agency to reclassify its emergency hormonal contraceptive ellaOne (ulipristal acetate 30mg) approved by the European Commission in early 2015 via the centralised procedure.

In an exclusive comment to the OTC.NewDirections team, Ibis Reproductive Health’s VP for Development & Public Affairs Britt Wahlin said: We are thrilled to be working with HRA Pharma in this effort that has been driven by demand from consumers and medical professionals. It’s past time we have an FDA approved OTC birth control pill, which would make it easier for women and men all across the country to determine how and when to have children and give them greater control over their lives and reproductive health. Currently, under the Affordable Care Act, most private insurance plans have to cover all types of FDA-approved birth control for women without any cost-sharing. This includes OTC methods used by women – though only if a healthcare provider prescribes them. We hope that women will be able to use their insurance for an OTC birth control pill without having to get a prescription.

A new law in Maryland is a promising direction. It will require coverage of OTC contraceptive medications without a prescription starting in 2018 and we hope more states will follow suit. Efforts are underway to dismantle the ACA and we have yet to learn what concrete plans there are to replace it. The birth control coverage provision is a crucial piece of the ACA. Millions of women have benefited from greater access to birth control and contraception is not one size fits all; insurance coverage of the full range of methods is critical so that women truly have a choice.

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Also, HRA Pharma’s US Portfolio Strategy Director Stéphanie Pradet told the OTC.NewDirections team: HRA Pharma is proud to partner with Ibis Reproductive Health and the OC OTC Working Group to bring to the US market a safe and effective over-the-counter contraceptive. At HRA, we are proud of our pioneering work to expand access to contraception for millions of women. We share the OC OTC Working Group’s commitment to increasing safe and effective options for preventing pregnancy and improving the reproductive health of women in the US.

Oral contraceptives are some of the best-studied medicines on the market today and enjoy longstanding support from medical and public health experts. The science is clear, and US experts including The American College of Obstetricians & Gynecologists, the American Medical Association and the American Academy of Family Physicians agree that oral contraceptives are appropriate as an over-the-counter option. We look forward to working together to build a future where each woman can get the safe and highly effective birth control method she prefers.

Male Contraceptive Has Moderate Trial Success

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The next frontier of sexual liberation is close – the male contraceptive is almost here!

For decades now, scientists have been progressively working towards developing birth control for men, and the recent news that the injected male contraceptive is now just as effective as its female counterpart is groundbreaking.

In a trial of 320 men, aged between 18 and 45, researchers found that, over a one-year period, a new hormone-based injection was 96% effective in preventing pregnancy.

The hormones injected into the men on the trial were shown to dramatically lower their sperm count by “switching off” the male reproductive system.

The drugs did however cause some unpleasant side-effects, meaning that the trial had to be halted early. Of the 320 participants, 20 experienced mood swings, depression, muscle pain and acne. Despite this, 75% of the participants said they would be happy to take the male contraceptive on a regular basis.

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Richard Anderson, a professor of clinical reproductive science and author of the study, said: “If you’re comparing it to other reversible male methods, it’s far better than the condom and it puts it in the same ballpark as the pill.”

The male contraceptive is not the only new and innovative form of protection that is set to be on offer. The predominantly male condom is now available in female form. The disposable contraceptive device, which is marketed by The Female Health Company, is the only female condom approved by the US FDA and cleared by the World Health Organization.

The condom provides dual protection against unintended pregnancy and sexually transmitted infections, offering what it claims to be a thoroughly safe sexual experience for both parties.

OTCs in Action Episode 10: “Modern” contraception

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This week, OTCs in Action are impacting the sexual health market with New Zealand’s approval of LifeStyles Dual Protect (Ansell for Starpharma) antiviral condom to help prevent pregnancy, HIV and other STD transmission; and EMA regulators’ recommendation for the European Commission to switch HRA Pharma’s ellaOne (ulipristal acetate) emergency hormonal contraceptive from Rx to OTC. ellaOne can prevent unintended pregnancy if taken within 120 hours (5 days) of intercourse; as opposed to current products, which are effective for only 72 hours.

In contrast, OTCs are not in action where they may be most needed…

About 225mn women in developing countries want to avoid pregnancy but are not using modern contraceptives, according to a report published this week by the Guttmacher Institute and the United Nations Population Fund. The study calculates it would cost on average US$25 per woman aged 15–49 to provide reproductive health services (including newborn care) to all women in developing regions each year.

Last month, Indian sterilisation camps came to the world’s attention when 13 women died after undergoing a sterilisation procedure for which they were compensated about US$10. The Wall Street Journal’s India Real Time reported that 4.5mn Indian women underwent sterilisation in the year that ended March 2013. In the same period, just 120,000 men were sterilised.

In the future, multipurpose prevention technologies (MPTs) will be the OTCs in Action to provide women with pregnancy and STD protection simultaneously in formats such as gels, films and devices. Dr Beth Young Holt, co-ordinator of The Initiative for MPTs, wrote in The Guardian this month: “Many of the newest MPTs in development are female-initiated and can be used discretely. Integrative MPT products can deliver an end run around stigma (associated with condom use in many cultures) that can be a barrier to HIV prevention.”

Lifestyle OTCs: Trends, Developments, Opportunities and Strategies was published by Nicholas Hall & Company this week. This report looks at the current market situation, taking in regulatory developments, marketers & brand activity, launches and A+P campaigns, illuminating where growth opportunities are for the future.