Will be available from September through selected pharmacies
The US drug regulator on Friday approved Palatin Technologies and Amag Pharmaceuticals' drug to restore sexual desire in premenopausal women, the latest attempt to develop a therapy that some call "female Viagra."
The therapy, Vyleesi, will compete in a market that has seen earlier attempts fail. Analysts said a drug that safely and effectively treats the loss of sexual desire in women can reach an annual turnover of about $ 1 billion.
Shares of Palatin rose 44% to $ 1.93, while shares of Amag rose 11.5% after the market.
Vyleesi, chemically known as bremelanotide, activates pathways in the brain involved in sexual desire, helping premenopausal women with hypoactive sexual desire disorder (HSDD).
The drug will compete with Addyi of Sprout Pharmaceuticals, a once-a-day, HSDD-approved pill in 2015 with a warning restricting alcohol use during medication.
It will be available from September through selected pharmacies.
Addyi was approved under intense pressure from defense groups, despite a review by Food and Drug Administration (FDA) scientists who found it minimally effective and possibly unsafe.
Vyleesi, which does not restrict alcohol use, is seen as having several advantages over Addyi, including tolerable side effects, fast acting nature and not having to take every day, according to analysts.
Side effects reported during clinical trials included mild to moderate nausea lasting no more than two hours and occurred mainly in the first three doses, Amag said. About 40% of patients in clinical trials were nauseated.
The drug is given as a shot in the abdomen or thigh using an auto-injector at least 45 minutes prior to expected sexual activity, with the FDA recommending that patients not take more than one dose in 24 hours or more than eight doses per month .
The drug was developed by Palatin and Amag holds the exclusive rights to sell in North America. Palatin will receive $ 60 million from Amag for approval as well as additional payments for certain sales and royalty milestones.
HSDD affects about 6 million women in the US, but few seek or receive treatment.
SVB analyst Leerink Ami Fadia said there would be a need for more direct consumer advertising through social media, which could help raise HSDD awareness.
"These women are suffering in silence and the market does not exist today," said William Heiden, CEO of Amag.
Ladenburg Thalmann analyst Michael Higgins predicts Vyleesi sales could reach $ 732 million by 2030.