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July 1, 2021Solosec Receives New Indication to Treat Common Sexually Transmitted Infection
July 1, 2021 – The U.S. FDA has approved a new indication for Solosec® (secnidazole) oral granules, manufactured by Lupin Pharmaceuticals, to treat trichomoniasis caused by Trichomonas vaginalis in adults.
Trichomoniasis is a common sexually transmitted disease caused by T. vaginalis, a protozoan (single-celled animal) parasite. An estimated 70% of infected individuals experience no signs or symptoms, which can mean they don’t know they have trichomoniasis. Without treatment, infections can last for months or years. Trichomoniasis can also increase the risk of getting or spreading other sexually transmitted infections. For pregnant females, trichomoniasis may increase chances of a preterm birth and of infants having a low birth weight.
In a clinical trial, Solosec achieved a 92.2% microbiological cure rate at study participants’ test of cure evaluations 6-12 days after treatment. With placebo, the microbiological cure rate was 1.5%. Because trichomoniasis is a sexually transmitted disease, both the infected individual and their sexual partner(s) should be treated with the same dose at the same time.
Recommended dosing under the new indication is a single 2g packet of Solosec granules taken once orally. The entire contents of the packet should be sprinkled onto applesauce, yogurt, or pudding and consumed within 30 minutes without chewing or crunching the granules. This can be followed with a glass of water to aid in swallowing.
Originally FDA approved in 2017, Solosec is also indicated to treat bacterial vaginosis in adult females.