Nella™ NuSpec™, VuSleeve® and VuLight® provide new products complimenting Lupin’s Specialty offering
Nella™ NuSpec™, VuSleeve® and VuLight® provide new products complimenting Lupin’s Specialty offering
BALTIMORE, June 9, 2020 /PRNewswire/ -- Lupin Pharmaceuticals Inc., the U.S. based wholly-owned subsidiary of Lupin Limited (Lupin), and Ceek Women’s Health (Ceek), a leading pioneer in modern gynecological care, today announced an agreement to add Ceek’s line of women’s health products to Lupin’s promotional offering in the United States, further enhancing the value that Lupin provides to OB/GYNs and their patients. The promotional arrangement includes detailing and demonstration of Ceek’s products, alongside Lupin’s women’s health flagship product, Solosec® (secnidazole) 2g oral granules, indicated for the treatment of bacterial vaginosis (BV), a common vaginal infection in adult women. Solosec® is a 5-nitroimidazole antimicrobial agent.
Offering the first innovative update to the vaginal speculum in nearly 150 years, the Nella™ NuSpec™ is the smarter reusable speculum. The NuSpec™ was developed after extensive prototyping and research to change the patient experience during gynecological exams. The VuSleeve® and the VuLight® are accessories to the speculum designed to provide easy visualization and access to the cervix. Ceek’s product line is designed to improve the quality of care for all women as well as in specific segments, including adolescents, transgender patients, rape or trauma patients, post-menopausal women and cancer survivors. Ceek has been the recipient of three prestigious product design awards including the 2020 Red Dot Award, the 2020 iF Award, and the 2019 Core77 Notable Design Award. Lupin will also be promoting another product currently in Ceek’s pipeline later in the year.
“We are excited to add these innovative offerings to our customers and patients,” said Jon Stelzmiller, President – Specialty, Lupin Pharmaceuticals, Inc. “This further emphasizes the Lupin commitment to women’s health and to improving the patient and provider experience.” Fahti Khosrowshahi, CEO of Ceek, added, “We are extremely excited to partner with Lupin. Lupin’s integrity and commitment to women’s health is unparalleled and this partnership is a pivotal milestone for Ceek as we transition to commercialization. The partnership with Lupin allows Ceek to launch our products nationally with a world-class field-force focused on OB/GYN providers.”
About Ceek Women’s Health
Ceek Women’s Health is a groundbreaking medical device company committed to improving women’s healthcare experiences by introducing innovative products for better pelvic exams. Founded in 2015, Ceek was inspired by founder Fahti Khosrowshahi’s personal experience enduring infertility treatment. Realizing that many of the devices used in gynecological care are antiquated, Fahti started Ceek to modernize tools and help women receive the care they deserve. Ceek creates new medical devices by bringing women’s perspectives to the table, updating care in a way that listens to and recognizes the needs of both the patients and clinicians.
For more information, please visit: https://ceekwomenshealth.com/
About Lupin Pharmaceuticals, Inc.
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.
Bacterial vaginosis (BV)
Bacterial vaginosis is the most common vaginal infection in the U.S. affecting more than 20 million women between the ages of 14 and 49 annually. Bacterial Vaginosis (BV) is an infection caused by an imbalance of bacteria naturally found in the vagina.3 Symptoms of BV include an unpleasant or fishy odor, discharge, thin, milky grayish-white, or excessive discharge, and sometimes itching, burning sensation or irritation.3,4 However, some women may have no symptoms.4 A healthy vagina has a natural balance of good and bad bacteria.1 An overgrowth of bad bacteria can occur when the vagina’s pH level (level of acidity) is disturbed. When this happens, bad bacteria are able to grow and overtake the good bacteria, which may lead to BV.2
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.3 Solosec® is easy to take, and one dose delivers a complete treatment, which can be taken at any time of day, without regard to the timing of meals.4 After one dose, Solosec® continues to treat BV for four days without any alcohol restriction – in vitro drug alcohol studies show Solosec® does not inhibit the enzyme that metabolizes alcohol. Because Solosec® is taken in one oral dose, it may be preferred by women who wish to avoid a multi-day treatment regimen.5
INDICATION
Solosec® (secnidazole) 2 g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis (BV) 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 click here for full Prescribing Information.
Solosec® is a registered trademark owned by Lupin Inc.
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.
1 Lewis FM, Bernstein KT, Aral SO. Vaginal microbiome and its relationship to behavior, sexual health, and sexually transmitted diseases. Obstet Gynecol. 2017(4);129:643-654. doi:10.1097/AOG.0000000000001932.
2 Kumar N, Behera B, Sagiri SS, Pal K, Ray SS, Roy S. Bacterial vaginosis: etiology and modalities of treatment—a brief note. J Pharm Bioallied Sci.2011;3(4):496-503. doi:10.4103/0975-7406.90102.
3 SOLOSEC® (secnidazole) Prescribing Information. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2019.
4 Data on File, Physician Research. Advantage Healthcare, Inc. Prepared December 23, 2014.
5 Broumas AG, Basara LA. Potential patient preference for 3-day treatment of bacterial vaginosis: responses to new suppository form of clindamycin. Advanced Therapy 2000;17(3):159-166.
For further information please contact -
Caren Begun
Green Room Communications
Email: caren@greenroompr.com
Tel: +1-201-396-8551
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SOURCE Lupin Pharmaceuticals, Inc.
