Health Care

FDA Approves New Injectable Drug to Boost Women's Sex Drive

FDA Approves New Injectable Drug to Boost Women's Sex Drive”

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Keep an eye on this pre-market jumper throughout the day to see if the drug maker will recoup any of its market losses since the bell. About 40% of patients in the clinical trials experienced nausea, most commonly with the first Vyleesi injection, and 13% needed medications for the treatment of nausea.

The US drug regulator on Friday approved drug Vyleesi manufactured by Palatin Technologies and Amag Pharmaceuticals'. The company declined to release price information.

"We are incredibly excited with the FDA's decision to approve the NDA for Vyleesi as a treatment for premenopausal women with HSDD", said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. The approval was based on women's responses to questionnaires that showed increases in sexual desires and decreases related to stress.

Interestingly, the search for a pill to treat women's sexual difficulties was once a top priority for numerous world's biggest drugmakers, including Pfizer, Bayer and Procter & Gamble. Side effects include nausea, vomiting, injection site reaction and headaches.

Marketed as Vyleesi, also known as bremelanotide, the medication is a shot that comes in a push pen device that can be self-administered as needed for premenopausal women who experience marked distress as a result of low sexual desire. It also could interfere with oral naltrexone, a drug for people with alcohol and opioid dependence, the FDA further said.

Now, Vyleesi promises treatment with a pill that would address a clinician's diagnosis of HSDD, which according to medical experts "is characterized as a lack or absence of sexual fantasies and desire for sexual activity (Wikipedia)". 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. Case in point: almost 21 percent of women experience major depression at some point in their life, and low libido is one of the most common red flags, according to Johns Hopkins Medicine. According to Palatin, approximately 6 million women meet the diagnostic criteria for generalized HSDD.

The search for a pill to treat women's sexual difficulties was once a top priority for numerous world's biggest drugmakers, including Pfizer, Bayer and Procter & Gamble.

Some have billed the drug as a "female Viagra", though Viagra acts on blood vessels, whereas bremelanotide acts on brain receptors.

Amag plans to market Vyleesi through social media and a website, unblush.com, that tells women having a low sex drive "is nothing to blush about".

Around the time of Addyi's approval in 2015, critics anxious "that doctors would just be prescribing this medication to anybody that came in saying that they were having an issue with their libido".



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