New drug for female thytosis! Rubin Pharmaceuticals Solosec single dose oral cure rate of more than 90%!

Solosec 2 g oral granulant is a 5-nitromide antimicrobial agent that is currently only approved by the FDA to treat bacterial vascular disease (BV) in adult females.
The drug is a single-dose oral therapy, and the entire contents of solosec bags should be sprinkled on apple pie, yogurt or pudding and eaten within 30 minutes without chewing or crushing the particles.
Solosec should not dissolve in any liquid.
the data, Rubin Pharmaceuticals will submit a new drug application (sNDA) for Solosec's treatment of thyloid disease to the FDA later this year.
is the most common non-viral sexually transmitted infection (STI) in the United States and is caused by a native animal parasite called vaginal caterpillar.
estimates that 3 to 5 million people are infected in the United States.
tricosomiasis is associated with a 2-3 times increased risk of HIV infection and with poor reproductive health outcomes, including infertility and premature birth.
the report is a multi-center, randomized, delayed treatment, placebo-controlled, double-blind Phase III study that included 147 adult female patients to assess the effectiveness and safety of single-dose oral Solosec granules in the treatment of thyloid disease.
study subjects were diagnosed with thymaid disease during screening visits (Visit 1, 1st visit, baseline examination) and were positive for vaginal caterpillar culture.
the first visit, subjects were randomly assigned to Solosec or a matching placebo on a 1:1 scale.
On the second visit (Visit 2, day 6-12), the subjects were assessed for a cure test (test-of-cure, TOC) and at this time (after sampling for TOC culture), they were treated with a placebo at the time of the baseline examination, and if the subject was treated with a placebo at the baseline examination, they were treated with a placebo.
followed up with the subjects to determine the remission of thymatosis and whether additional treatment was required.
the main endpoint of the study was the proportion of patients who reached microbiological cures during TOC visits.
Microbiological cures are defined as modified intentional therapy (mITT) groups (randomized subjects who are positive for vaginal caterpillar culture at all baselines, gonorrhea and chrysanthal negative) and negative for vaginal caterpillar culture (e.g., inPouch TV tests negative for vaginal caterpillars).
results showed that the study reached its main endpoint: in the mITT group, 92.2% of patients in the Solosec group (59/64) achieved a microbiological cure, while in the placebo group 1.5% (1/67) (p.lt;0.001).
in the per-protocol population (PPP) group, Solosec had a cure rate of 94.9% (56/59), while a placebo cure rate was 1.7% (1/60) (p.lt;0.001).
Solosec is well-to-do.
adverse reactions were V vaginal candyia (2.7%) and nausea (2.7%).
adverse events were not observed in the test.
The results of the Phase III study are very encouraging and, once new adaptations are approved, could support Solosec's application as a treatment for throossis in clinical practice," said Christina Muzny, M.D., M.D., M.D., of the University of Alabama at Birmingham and a participant in the summary of the
IDSOG meeting.
increases the risk of HIV infection, disproportionately affects African-American women, and can lead to adverse health consequences.
it is vital that high-risk women are screened and treated with easy-to-use treatments that can help improve patient compliance.
Dr Gregory Kaufman, Senior Vice President of Global Clinical and Medical Affairs at Rubin Pharmaceuticals, said: "Thyroid disease is the most common non-viral sexually transmitted infection affecting an estimated 3-5 million people in the United States, and we look forward to working with the FDA when applying for this new adaptation.
" Original Origin: Lupin Presents Phase 3 Data for Solosec? (secnidazole) ProjectIng Large Response Rate in Female Patients with Trichomoniasis.