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.
While on the positive side, the drug is to be used "only when you need it", on the downside, "its a shot" causing side effects like nausea.
Cynthia Pearson, executive director of the National Women's Health Network, warned women to avoid using the drug "until more is known about its safety and effectiveness", pointing out that that the developers had not yet published the results of their clinical trials. But the company declined to release price information.
Vyleesi will be available to premenopausal women with hypoactive sexual desire disorder that is characterized by chronically low or nonexistent sexual desire which can often cause distress. The approval was based on women's responses to questionnaires that showed increases in sexual desires and decreases related to stress. Still, more than 90% of women who experienced nausea stayed in the drug trial, suggesting that either their nausea was mild or they felt that the benefits of the drug outweighed the side effect, Kingsberg said.
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 reportedly. It also could interfere with oral naltrexone, a drug for people with alcohol and opioid dependence, the FDA said. HSDD is a condition "characterized by low sexual desire" that can not be attributed to an outside cause, such as an existing medical or psychiatric condition, existing problems within the sexual relationship, or side effects of another medication, according to the FDA's announcement.
Experts say the diagnosis is the most common type of sexual dysfunction among women, estimated to affect between 8% to 10% of women. According to Palatin, approximately 6 million women meet the diagnostic criteria for generalized HSDD.
UMass's Johnson said drugs should not be the first choice for treating women's sexual problems. Drugs used to treat male sexual dysfunction, such as sildenafil (brand name Viagra), mainly target an enzyme called phosphodiesterase 5 (PDE5), which plays a role in regulating blood flow to the penis.
While the exact mechanism of action is unknown, Vyleesi is believed to bind to melanocortin receptors in the central nervous system that are thought to be associated with sexual function.
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".