Health & Fit: FDA refutes claims about libido-boosting drug - PressFrom - US
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Health & FitFDA refutes claims about libido-boosting drug

00:00  12 september  2019
00:00  12 september  2019 Source:   msn.com

New drug to boost women's sex drive approved in US

New drug to boost women's sex drive approved in US Women will soon have another drug option, Vyleesi, which is designed to boost low sex drive. It's delivered via a shot that raises sexual interest for several hours. 

The U.S. Food and Drug Administration refutes an announcement from Sprout Pharmaceuticals that it has relaxed its restrictions on the company’s libido - boosting drug Addyi. FDA refutes claims by Raleigh’s Sprout Pharmaceuticals about its libido - boosting drug .

Bremelanotide becomes the second FDA -approved drug for hypoactive sexual desire disorder in premenopausal women. It is self-injected at least The FDA had until June 23 to complete the review of bremelanotide's new drug application (NDA) under the Prescription Drug User Fee Act (PDUFA).

RALEIGH, N.C. — The U.S. Food and Drug Administration is refuting recent claims by Raleigh-based Sprout Pharmaceuticals that its drug, the female libido pill Addyi, no longer requires health care practitioners or pharmacies to be certified by the FDA to prescribe or dispense the pill.

FDA refutes claims about libido-boosting drug© Rick Kern/Getty Images North America/TNS Cindy Eckert, Sprout Pharmaceuticals CEO attends the Inc. Founders House on March 10, 2019 in Austin, Texas. The FDA is refuting recent claims by Sprout Pharmaceuticals that its drug Addyi no longer requires health care practitioners or pharmacies to be certified by the FDA to prescribe or dispense the pill.

Amanda Turney, a press officer for the FDA, reached out to The News & Observer following a news release by Sprout to say that pharmacies and practicitioners still need to be certified under the Risk Evaluation and Mitigation Strategy (REMS) program to prescribe Addyi, which treats hypoactive sexual desire disorder in women.

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Proponents claim the Food and Drug Administration is applying a double standard to its review of a drug some call the female Viagra. In the documents released in advance of the hearing, FDA reviewers concluded that the drug could boost libido in some women and increase the number of

The Food and Drug Administration ( FDA ) recently approved a new drug to treat low sex drive in women. The drug , called bremelanotide (brand name Vyleesi) has been approved to treat premenopausal women with hypoactive sexual desire disorder (HSDD), a condition in which low

Last week, Sprout had celebrated in a release to the media that the requirement had been eliminated. Sprout CEO Cindy Eckert told the N&O that the move would likely lead to a boost in sales and that the company would increase its marketing budget for the drug.

But that press release has now been deleted from the company website and from third-party websites that had circulated it.

The FDA spokesperson also noted that the agency had not eliminated its warnings about using alcohol with the drug. The FDA noted that alcohol use with the pill can cause an increased risk of fainting. Because of that, it has required a label warning against drinking alcohol while using Addyi.

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A drug that grew out of a search for a sunless tanning agent won U.S. approval Friday as the second medication to treat premenopausal women who Drug companies have been pursuing pharmaceutical fixes for female sexual dysfunction ever since Viagra’s blockbuster debut for men two decades ago.

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In April, the FDA determined that changes should be made to Addyi’s labeling to clarify that while there is still a concern about consuming alcohol and taking Addyi, it no longer suggested that alcohol should be completely avoided. It now suggests stopping alcohol intake two hours before taking Addyi.

The FDA noted in its April release that it ordered the labeling change for Sprout because it had not reached an agreement with the company — which had asked for a removal of the warning and the contraindication about alcohol. The FDA determined that removal of that information was not acceptable, then added that it is rare that the agency doesn’t reach an agreement with a company.

In its release last week, Sprout said it no longer needed the warning or contradiction on the labeling. On its website, there is still a link to a label without the REMS requirement or the contraindication.

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The FDA is scheduled to make its decision on the drug by Tuesday. Sprout’s drug was actually acquired from Boehringer Ingelheim in 2011. In a video, Slate featured Harvard Medical School professor Abraham Morgentaler, claiming that testosterone could boost men’s energy and libido .

WASHINGTON (AP) — The Food and Drug Administration has approved the first prescription drug designed to boost sexual desire in women, a milestone long sought Iglesia said she has occasionally resorted to prescribing testosterone creams to boost women's libido , a use not approved by the FDA .

Eckert, who previously went by the last name Whitehead, was not available for comment about the FDA’s response. A spokeswoman for Sprout declined to comment on why the company deleted its press release from last week.

The spokeswoman said the press release was still accurate in regard to its claims around the FDA’s softening of its stance about alcohol use, but that the company is still in conversation with the agency about the REMS and contradindication section.

The spokeswoman added that, as the company understood its communications with the FDA, the REMS condition was being dropped.

“The FDA is still working with Addyi to finalize the updated recommendation as it is related to REMS and the alcohol contraindication,” the spokeswoman for Sprout said.

The news comes as Sprout works to turn around the fortunes of Addyi, which was the world’s first pill to boost women’s sex drive.

After originally selling the drug to Valeant Pharmaceuticals in 2015, Addyi never really got off the ground with consumers. After Valeant got into legal troubles, the company gave the drug back to Sprout, which has now started to market it on its own.

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Eckert told the N&O last week that the number of women using Addyi has increased every quarter since it bought the drug back from Valeant Pharmaceuticals in 2017.

Addyi also has more competition now, as the FDA approved a competing drug earlier this summer.

Gallery: Your Low Sex Drive Could Be a Sign of a More Serious Health Issue (Provided by Women's Health)

FDA refutes claims about libido-boosting drug

The first pill for low sex drive in women now has competition.
Approved by the FDA in June, Vyleesi is now on the market.

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