MUMBAI, India and BALTIMORE, Maryland, May 4, 2020 /PRNewswire/ -- Lupin Pharmaceuticals Inc. (Lupin) today announced positive top-line results from its pivotal Phase 3 clinical trial to assess efficacy and safety of single-dose Solosec® (secnidazole) 2g oral granules in 147 female patients with trichomoniasis. Trichomoniasis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S. The trial demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec® as compared to placebo (p<0.001). Based on the data, Lupin plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Solosec® for the treatment of trichomoniasis in the second half of 2020. Solosec® is approved by the FDA to treat bacterial vaginosis (BV) in adult women.
The trial met its primary endpoint of microbiological cure at the test-of-cure (TOC) visit on study Day 6-12, defined as a negative Trichomonas vaginalis culture. The predefined primary efficacy endpoint, defined as Microbiological Cure (i.e., InPouch™ TV test negative for T. vaginalis) at the Test-Of-Cure visit (Day 6-12) in the modified Intent-To-Treat (mITT) population (all randomized subjects who were culture positive for T. vaginalis and negative for gonorrhea and chlamydia at baseline), was 92.2% (59/64) for Solosec® (secnidazole) versus 1.5% (1/67) for placebo ( p<0.001). In the Per-Protocol population, the cure rate was 94.9% (56/59) for Solosec® (secnidazole) versus 1.7% (1/60) for placebo (p<0.001). Solosec® (secnidazole) was generally well-tolerated with the most commonly reported adverse events being vulvovaginal candidiasis (2.7%) and nausea (2.7%). No serious adverse events were observed.
"Trichomoniasis impacts an estimated 3 to 5 million people in the U.S.," Gregory Kaufman, M.D., Senior Vice President, Global Clinical and Medical Affairs, Specialty at Lupin said. "We are encouraged by the topline results of our clinical trial, look forward to finalizing the analysis, and working with the FDA to provide a new single-dose therapy option to physicians and patients, to treat this disease."
About the Phase 3 Study
The Phase 3 trial is a multicenter, randomized, delayed treatment, placebo-controlled, double-blind study to evaluate the effectiveness and safety of a single oral dose of Solosec® (secnidazole) granules for the treatment of trichomoniasis in adult women. Subjects included female patients with a diagnosis of trichomoniasis at the screening visit (Visit 1, baseline) that was confirmed by a positive culture for T. vaginalis. At Visit 1, subjects were randomly assigned in a 1:1 ratio to either Solosec® or matching placebo. Subjects were evaluated for TOC at the second visit (Visit 2, Day 6 -12), at which (following sampling for the TOC culture), subjects also received active treatment if they had received placebo at baseline, and subjects received placebo if they had received active treatment at baseline. Subjects were then followed at subsequent visits for resolution of trichomoniasis as well as any need for additional therapy.
Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas vaginalis.1 An estimated 3 to 5 million people have the infection,2 with African American women having a nearly ten times higher risk of being affected compared with non-Hispanic white women.3 Trichomoniasis is four-to-five times more prevalent in women compared to men.3 Signs and symptoms in women can include itching, burning, redness or soreness of the genitals, discomfort with urination and vaginal discharge.1 However, most infected persons (70%-85%) have minimal or no symptoms, and untreated infections might last for months to year.1.4.8 Trichomoniasis is associated with a two- to three-fold increased risk of HIV infection,5.6 as well as adverse reproductive health outcomes, including infertility and preterm birth.7 Up to 53% of women with HIV infection also have T. vaginalis, which is associated with a significantly increased risk of contracting pelvic inflammatory disease (PID).8 Routine screening of asymptomatic women with HIV infection for T. vaginalis is recommended because of the adverse events associated with asymptomatic trichomoniasis and HIV infection.8 Patients receiving care in high-prevalence settings (e.g. STD clinics) and asymptomatic patients at high risk for infection (e.g., persons with multiple sex partners, history of STDs) may also be considered for screening.8
Solosec® (secnidazole) 2g oral granules is the first and only single-dose oral prescription treatment option to treat bacterial vaginosis (BV), a common vaginal infection, in adult women.9 Solosec® is easy to take, and one oral dose contains a full course of treatment.9.10 Women who are prescribed Solosec® sprinkle the entire packet of granules onto applesauce, yogurt, or pudding and eat the entire mixture without chewing the granules within 30 minutes. One dose delivers a complete treatment and Solosec® can be taken at any time of day, without regard to the timing of meals.9 There is no need to avoid any foods or drinks, including alcohol, with Solosec®. Laboratory studies show Solosec® does not inhibit the enzyme that processes alcohol in the body.9 Because Solosec® is taken in one oral dose, it may be preferred by women who wish to avoid a multi-day treatment regimen.11
SOLOSEC® (secnidazole) 2 g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women.
DOSAGE AND ADMINISTRATION
SOLOSEC® is a single-dose therapy for oral use. The entire contents of SOLOSEC® packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC® is not intended to be dissolved in any liquid.
IMPORTANT SAFETY INFORMATION
SOLOSEC® is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.
Vulvo-vaginal candidiasis may develop with SOLOSEC® and require treatment with an antifungal agent.
Potential risk of carcinogenicity is unknown and has not been studied. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC®.
Most common adverse reactions observed in clinical trials (incidence ≥ 2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Please see accompanying full Prescribing Information.
Solosec® is a registered trademark owned by Lupin Inc.
About Lupin Pharmaceuticals
Lupin Pharmaceuticals, Inc. is the U.S. based wholly owned subsidiary of Lupin Limited, and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals Inc.'s branded pharmaceuticals division, is the provider of products designed to help prevent and manage women's health conditions with serious health consequences.
Safe Harbor Statement under the U.S. private Securities Litigation Reform Act of 1995
This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents Management's expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.
2 American College of Obstetricians and Gynecologists. Vaginitis in Nonpregnant Patients. ACOG Practice Bulletin No. 215. Obstet Gynecol 2020;135(1):e1-17.
3 Flagg EW, Meites E, Phillips C, Papp J, Torrone EA. Prevalence of Trichomonas vaginalis Among Civilian, Noninstitutionalized Male and Female Population Aged 14 to 59 Years: United States, 2013 to 2016. Sex Transm Dis. 2019;46(10):e93–e96. doi:10.1097/OLQ.0000000000001013.
4 Daugherty M. Prevalence of Trichomonas vaginalis Infection Among US Males, 2013-2016. Clinical Infectious Diseases. 2019 Feb.; 68(3): 460–46.
5 McClelland, RS. Infection with Trichomonas vaginalis increases the risk of HIV-1 acquisition. Journal of Infectious Diseases. 2007 Mar 1;195(5):698-702.
6Van Der Pol, B. Trichomonas vaginalis infection and human immunodeficiency virus acquisition in African women. Journal of Infectious Diseases. 2008 Feb;197(4):548-54.