Primary endpoint successfully achieved in Phase 3 clinical trial of 147 patients
Solosec® 2g oral granules was generally well-tolerated among study subjects
Lupin plans to submit a supplemental New Drug Application for Solosec® to the FDA for the treatment of trichomoniasis in H2 2020
MUMBAI, India and BALTIMORE, MD, USA I May 4, 2020 I 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.
About Trichomoniasis
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
About Solosec
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
INDICATION
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.
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.
© 2020 Lupin Pharmaceuticals, Inc. All rights reserved.
References:
1 Centers for Disease Control and Prevention. Trichomoniasis – CDC Fact Sheet. Available at: https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm. Accessed April 21, 2020.
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.
6 Van Der Pol, B. Trichomonas vaginalis infection and human immunodeficiency virus acquisition in African women. Journal of Infectious Diseases. 2008 Feb;197(4):548-54.
7 Sobel JD, Mitchell C. Trichomoniasis. UpToDate. Available at: https://www.uptodate.com/contents/trichomoniasis. Accessed April 22, 2020.
8 Centers for Disease Control and Infection. 2015 Sexually Transmitted Diseases Treatment Guidelines. Trichomoniasis. Available at: https://www.cdc.gov/std/tg2015/trichomoniasis.htm. Accessed April 28, 2020.
9 SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2017.
10 Data on File, Physician Research. Advantage Healthcare, Inc. Prepared December 23, 2014
11 Broumas AG, Basara LA. Potential patient preference for 3-day treatment of bacterial vaginosis: responses to new suppository form of clindamycin. Adv Ther. 2000;17(3):159-166.
SOURCE: Lupin Pharmaceuticals
Post Views: 157
Primary endpoint successfully achieved in Phase 3 clinical trial of 147 patients
Solosec® 2g oral granules was generally well-tolerated among study subjects
Lupin plans to submit a supplemental New Drug Application for Solosec® to the FDA for the treatment of trichomoniasis in H2 2020
MUMBAI, India and BALTIMORE, MD, USA I May 4, 2020 I 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.
About Trichomoniasis
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
About Solosec
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
INDICATION
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.
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.
© 2020 Lupin Pharmaceuticals, Inc. All rights reserved.
References:
1 Centers for Disease Control and Prevention. Trichomoniasis – CDC Fact Sheet. Available at: https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm. Accessed April 21, 2020.
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.
6 Van Der Pol, B. Trichomonas vaginalis infection and human immunodeficiency virus acquisition in African women. Journal of Infectious Diseases. 2008 Feb;197(4):548-54.
7 Sobel JD, Mitchell C. Trichomoniasis. UpToDate. Available at: https://www.uptodate.com/contents/trichomoniasis. Accessed April 22, 2020.
8 Centers for Disease Control and Infection. 2015 Sexually Transmitted Diseases Treatment Guidelines. Trichomoniasis. Available at: https://www.cdc.gov/std/tg2015/trichomoniasis.htm. Accessed April 28, 2020.
9 SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2017.
10 Data on File, Physician Research. Advantage Healthcare, Inc. Prepared December 23, 2014
11 Broumas AG, Basara LA. Potential patient preference for 3-day treatment of bacterial vaginosis: responses to new suppository form of clindamycin. Adv Ther. 2000;17(3):159-166.
SOURCE: Lupin Pharmaceuticals
Post Views: 157
