Author Interviews, Infections, OBGYNE / 16.05.2020

MedicalResearch.com Interview with: SCYNEXIS IncMarco Taglietti, M.D. President and Chief Executive Officer SCYNEXIS Inc Dr. Taglietti discusses SCYNEXIS’ announcement of positive results from its second Phase 3 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for vaginal yeast infection.  MedicalResearch.com: What is the background for this study? Response:  The VANISH-306 study is one of two Phase 3 randomized, double-blind, placebo-controlled, multi-center studies designed to demonstrate the superiority of oral ibrexafungerp to placebo as a treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. Ibrexafungerp is a novel oral/intraveneous broad-spectrum antifungal in late stage development for multiple indications, from the treatment and prevention of vaginal yeast infections to life-threatening invasive fungal infections in the hospital setting. The VANISH-306 study was conducted in 42 centers in the US and EU and enrolled 449 patients. Patients were randomized to oral ibrexafungerp (two doses of 300mg taken 12 hours apart for one day) or placebo in a 2:1 ratio The primary endpoints included clinical cure rate, defined as the complete resolution of all signs and symptoms at the test-of-cure visit (Day-10) and secondary endpoints included mycological eradication and change in signs and symptoms scores compared to baseline at both day 10 and follow-up visit (Day-25). The VANISH-306 study reported positive topline data which showed that 63.3% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. The first study in the VANISH program was VANISH-303, a US-based study, had an identical design to the VANISH-306 study. The VANISH-303 study reported positive topline data in November 2019 which showed that 50.5% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. Both VANISH studies showed a highly significant statistical difference in the primary and secondary efficacy endpoints. The product was well tolerated. (more…)
Abbvie, Author Interviews, OBGYNE, Pain Research / 26.07.2018

MedicalResearch.com Interview with: Dr. Dawn Carlson MD MPH Vice President, General Medicine Development AbbVie  MedicalResearch.com: Please provide some background on this announcement. Would you briefly explain what endometriosis is? Whom does it affect and how does it interfere with quality of life? Response: Endometriosis is one of the most common gynecologic disorders in the U.S that affects an estimated one in 10 women of reproductive age. It occurs when tissue similar to the lining of the uterus starts growing outside of the uterus, where it doesn’t belong. The symptoms of endometriosis, including pain with menstrual periods and between periods, and with sexual intercourse, can be debilitating and significantly impact day-to-day activities of women’s lives, personally and professionally. Unfortunately, women with endometriosis can suffer for up to 10 years and visit multiple physicians before receiving a proper diagnosis. Unresolved endometriosis pain results in higher healthcare costs from emergency department visits and repeat surgeries.  (more…)
Author Interviews, HIV, OBGYNE, Pediatrics, Pediatrics, STD / 24.07.2018

MedicalResearch.com Interview with: Monika K. Goyal, M.D., M.S.C.E., senior study author Assistant professor of Pediatrics and Emergency Medicine Children’s National Health System Washington, DC  MedicalResearch.com: What is the background for this study? Response: Patients with pelvic inflammatory disease (PID) are at an increased risk for syphilis and HIV. We know that adolescents account for 20 percent of the 1 million cases of PID that are diagnosed each year. We also know that an estimated one in four sexually active adolescent females has a sexually transmitted infection (STI). While screening for syphilis and HIV is recommended when diagnosing PID, actual screening rates among adolescents have been understudied. This multi-center study aimed to quantify rates of HIV and syphilis screening in young women diagnosed with . pelvic inflammatory disease in pediatric emergency departments and to explore patient- and hospital-specific characteristics associated with screening for these two sexually transmitted infections. (more…)