Tuesday February 25, 2020

US: New Drug to Boost Low Sex Drive in Women

The drug’s developer could also face some of the same hurdles that have plagued the lone pill previously approved

0
//
Drug, Sex Drive, US
The Food and Drug Administration campus in Silver Spring, Maryland. VOA

U.S. women will soon have another drug option designed to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours.

The medication OK’d Friday by the Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s. The other drug is a daily pill.

The upside of the new drug “is that you only use it when you need it,” said Dr. Julia Johnson, a reproductive specialist at UMass Memorial Medical Center who was not involved in its development. “The downside is that it’s a shot — and some people are very squeamish.”

The drug’s developer, Amag Pharmaceuticals, could also face some of the same hurdles that have plagued the lone pill previously approved for the condition, including unpleasant side effects and limited insurance coverage. The company declined to release price information.

Drug, Sex Drive, US
U.S. women will soon have another drug option designed to boost low sex drive. Pixabay

The FDA approved the new drug, Vyleesi (pronounced vie-LEE’-see), for premenopausal women with a disorder defined by a persistent lack of interest in sex, causing stress. The most common side effect in company studies was nausea. The approval was based on women’s responses to questionnaires that showed increases in sexual desire and decreases in stress related to sex. The women didn’t report having more sex, the original goal for the drug.

“Women are not desiring more sex. They want better sex,” said Dr. Julie Krop, Amag’s chief medical officer.

Flushing, injection site reactions and headache are other common side effects.

Women with high blood pressure or heart disease should not take the drug because increases in blood pressure were observed after injections, the FDA said. It also could interfere with oral naltrexone, a drug for people with alcohol and opioid dependence, the FDA said.

Also Read- Iranian Hackers Wage Offensive Cyberattacks Amid Tensions with US

Because so many factors affect sexual desire, doctors must rule out other causes before diagnosing the condition, including relationship issues, medical problems and mood disorders. The condition, known as hypoactive sexual desire disorder, is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.

Still, the pharmaceutical industry has long pointed to surveys — some funded by drugmakers — suggesting that it is the most common female sexual disorder in the nation, affecting roughly 1 in 10 women. Amag estimates nearly 6 million U.S. women meet the criteria for the drug.

Cynthia Pearson, executive director of the National Women’s Health Network, urged women to avoid using the drug “until more is known about its safety and effectiveness.” She noted in a statement that Amag had not yet published full clinical trial results.

The search for a pill to treat women’s sexual difficulties was once a top priority for many of the world’s biggest drugmakers, including Pfizer, Bayer and Procter & Gamble. Those companies and others studied and later abandoned drugs acting on blood flow, testosterone and other targets.

Drug, Sex Drive, US
The medication OK’d Friday by the Food and Drug Administration is only the second approved to increase sexual desire. Pixabay

Vyleesi acts on receptors for a brain-stimulating hormone called melanocortin, which is associated with sexual arousal and appetite in both men and women.

Waltham, Massachusetts-based Amag plans to pitch the drug to consumers through social media, including a website called unblush.com that tells women that low sex drive “is nothing to blush about.”

Amag’s campaign has some of the hallmarks that helped launch the first female libido drug, Addyi, a once-a-day pill approved in 2015. The FDA decision followed a contentious four-year review that included a lobbying effort funded by Addyi’s maker, Sprout Pharmaceuticals, which framed the lack of female sex drugs as a women’s rights issue.

Women taking Addyi showed a slight uptick in “sexually satisfying events” per month and improved scores on psychiatric questionnaires. Those results were only slightly better than what women taking a placebo reported, but they were significant enough to meet FDA effectiveness standards.

Also Read- Tips on How to Click a Better Selfie

The pink pill — originally developed as an antidepressant — was ultimately approved with a bold warning that it should not be combined with alcohol, due to risks of fainting and dangerously low blood pressure.

Most insurers refused to cover the drug, citing lackluster effectiveness, and many women balked at the $800-per-month price. Last year, Sprout slashed the price to $400. It was prescribed just 6,000 times last year, according to investment analyst data.

UMass’s Johnson said drugs should not be the first choice for treating women’s sexual problems. Instead, she recommends counseling to help women “separate all the stresses of life” from their sex life.

“But if that doesn’t work, having a medication that may help is worth trying,” she said. (VOA)

Next Story

American Biotech Company Works with Chinese Officials to Test Drug Against Coronavirus

Trials to Test Ebola Drug's Potential to Prevent, Treat Coronavirus

0
Coronavirus
An American biotech company says it is working with Chinese authorities to determine the efficiency of a drug that can fight coronavirus. Pixabay

By Natalie Liu

An American biotech company says it is working with Chinese authorities to determine whether the antiviral drug remdesivir may provide an effective treatment for victims of the fast-spreading coronavirus known as COVID-19. The Chinese researchers hope to have the answer by May 1.

Officials of Gilead Sciences, which invented remdesivir as a treatment for Ebola and another disease, told VOA the company has initiated two clinical trials among infected patients “to determine the safety and efficacy of remdesivir as a potential treatment for the coronavirus.”

The trials have been warmly welcomed in China, where the nation’s official news agency celebrated the launch with a front page article. Anxious Chinese citizens have noted that the four syllables of remdesivir resemble the phrase as renmin-de-xi-wang, or people’s hope.

Coronavirus
A medical worker holds a thermometer to check a passenger’s temperature at a checkpoint as the country is hit by an outbreak of the coronavirus in Susong County, Anhui province, China. VOA

There are also more scientific reasons to be hopeful, including the case of an American coronavirus patient who experienced a speedy recovery in January, just 24 hours after being given remdesivir. Before the drug was administered, his symptoms had shown signs of worsening.

The first trial began enrolling patients on February 6, said a written statement from Gilead, which says it has provided China with “enough doses of remdesivir to treat up to 500 trial participants.” A Shanghai-based media outlet reported having seen a customs clearance form showing that 2,843 boxes of remdesivir arrived in Beijing on February 4.

The next day, a conference dedicated to the official launch of clinical trials took place at the Jinyintan Hospital in Wuhan, led by Dr. Bin Cao and his colleague Dr. Chen Wang, both top scientists practicing at the China-Japan Friendship Hospital in Beijing. Jinyintan Hospital has been treating some of the most critical COVID-19 cases since the outbreak began.

Gilead confirmed the trials are “being coordinated by the China-Japan Friendship Hospital in Beijing.” A filing registered with the U.S. National Library of Medicine lists the Beijing-based Capital Medical University as the trial’s main sponsor and Cao, a specialist in pulmonary critical care at the China-Japan Friendship Hospital, as the “responsible party.”

Research shows promise

In a scientific paper based on animal studies and published last week, scientists found remdesivir to be effective both for the prevention and treatment of the deadly Middle East Respiratory Syndrome coronavirus (MERS-CoV,) which is known to bear resemblances to COVID-19.

“Remdesivir prevented disease when administered before infection and improved the condition of macaques [monkeys] when given after the animals already were infected,” said scientists at the National Institute of Allergy and Infectious Diseases’ Rocky Mountain Laboratories in Hamilton, Montana.

Coronavirus
A medical worker calls his colleague inside an isolated ward at Jinyintan Hospital in Wuhan, the epicenter of the novel coronavirus outbreak, in Hubei province, China. VOA

Dr. Emmie de Wit, Chief of the Molecular Pathogenesis Unit in the Laboratory of Virology at the Montana facility, told VOA that she and her colleagues conducted their studies and submitted their results for review “well before the world knew of the outbreak in Wuhan.” De Wit said she and her colleagues learned about the coronavirus outbreak on Dec. 31.

Wuhan trials

In the Wuhan study, participants are divided into two groups — those “who have developed more severe clinical manifestations” such as requiring oxygen, and those who do not require oxygen.

“Patients will receive 10 days of intravenously administered remdesivir. The primary endpoint of both studies involves clinical improvement 28 days after treatment,” according to Gilead. Cao reported that 200 mg of remdesivir would be given to a group of patients on day one, followed by 100 mg once-daily “maintenance doses” for nine additional days.

Also Read- Russia Allows Chinese Nationals with Business Visas Despite Entry Ban

Patients in a control group were to be given placebos. To ensure objectivity, the identities of the patients receiving the placebos are masked from the participants, care providers, researchers and outcome assessors.

The researchers say they aim to complete the trials by April 3 and evaluate the results by May 1. (VOA)