Mumbai, India–headquartered Lupin Pharmaceuticals (NYSE:LUPIN) has received an expanded indication for Solosec (secnidazole) to cover the treatment of trichomoniasis in adult patients and their partners.
The drug scored an initial FDA approval in 2017 for bacterial vaginosis (BV) in adult women.
Solosec is now the only single-dose oral drug that has an FDA indication for both trichomoniasis and BV.
The most recent approval follows a Phase 3 clinical trial that showed a 92.2% cure rate for patients with trichomoniasis, a common sexually transmitted disease (STD) resulting from infection with a protozoan parasite. CDC estimated there were two million trichomoniasis infections in the U.S. in 2018. Only about 30% of those with the condition, however, develop symptoms.
In the Phase 3 trial mentioned above, clinical trial investigators reported no serious adverse events. Some 2.7% of drug recipients in the trial had vulvovaginal candidiasis and 2.7% had nausea.
The infection, however, can lead to adverse health effects in women, including infertility, preterm birth and pelvic inflammatory disease.
Filed Under: Drug Discovery