Healthcare Industry News: HSMN NewsFeed
News Release - April 2, 2018
Duchesnay USA Announces Launch of Bonjesta(R) (doxylamine succinate - pyridoxine hydrochloride) in the United StatesROSEMONT, PA, April 2, 2018 -- (Healthcare Sales & Marketing Network) - Duchesnay USA, a pharmaceutical company specializing in women's health, announced the launch of Bonjesta® (doxylamine succinate and pyridoxine hydrochloride), multilayer extended-release tablets. Bonjesta is indicated for the treatment of nausea and vomiting of pregnancy ("NVP") in women who do not respond to conservative management.1
NVP, commonly known as morning sickness, is a medical condition that affects up to 85 percent of pregnant women.2 NVP can be different for each woman, with symptoms including: nausea, gagging, retching, dry heaving, and vomiting. For most pregnant women, symptoms generally cease at approximately 14 to 16 weeks. However, some women can experience symptoms throughout their pregnancy.3,4 Impacts of NVP also include economic burdens, with NVP being directly linked to hospitalization, emergency room visits and time lost from work among employed women. NVP is also linked to instances of restricted activity and impaired job performance.5,6
"Duchesnay is pleased to provide a multilayer extended-release treatment for expectant mothers to effectively and easily manage morning sickness symptoms throughout the day and night," said Éric Gervais, executive vice-president of Duchesnay, Inc. "The combination of ingredients found in Bonjesta® is a proven NVP treatment option with a 60-year safety record of use in market for millions of mothers and their babies, globally."
Bonjesta® received FDA approval in 2016 based on the safety and efficacy data from Diclegis® (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, and three clinical pharmacology studies: a single-dose bioequivalence study, a multiple-dose bioequivalence study and a food-effect study.1
Bonjesta® is a multilayer, extended-release formulation that is designed to provide both fast-acting and long-lasting symptom relief. A reduced pill burden (maximum daily dose of two tablets)7 could also improve patient adherence.
The American College of Obstetrics and Gynecology (ACOG) recommends the combination of ingredients in Bonjesta® as first-line pharmacotherapy for the treatment of NVP after conservative management has failed.8
Bonjesta® will have dedicated affordability programs, including copay assistance and a dedicated patient assistance program for patients in need.
More information at www.bonjesta.com.
ABOUT BONJESTA® EXTENDED-RELEASE TABLETS
Bonjesta® is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.
LIMITATIONS OF USE
It is not known if Bonjesta® is safe and effective in women with severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum. Women with this condition may need to be hospitalized.
IMPORTANT SAFETY INFORMATION
Bonjesta® is intended for use in pregnant women.
Do not take Bonjesta® if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Bonjesta®. Please refer to the Patient Information leaflet for the complete list of ingredients. You should also not take Bonjesta® in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse central nervous system (CNS) effects of Bonjesta®. Please ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including Marplan, Nardil, Emsam, Eldepryl, Zelapar, and Parnate.
The absorption and action of Bonjesta® may be impacted when tablets are taken with food. Therefore, you should take Bonjesta® on an empty stomach with a glass of water.
The most common side effect of Bonjesta® is drowsiness. Do not drive, operate heavy machinery, or do other activities that need your full attention unless your healthcare provider says that you may do so.
Do not drink alcohol, or take other CNS depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Bonjesta®. Severe drowsiness can happen or become worse causing falls or accidents.
These are not all the possible side effects of Bonjesta®. Call your doctor for medical advice about side effects.
Bonjesta® should be used with caution in women who have certain medical conditions, such as asthma, or eye problems called increased intraocular pressure or narrow angle glaucoma, stomach problems called stenosing peptic ulcer or pyloroduodenal obstruction, a bladder problem called urinary bladder-neck obstruction, or who are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed, so he/she can assess if Bonjesta® is right for you. Bonjesta® can pass into your breast milk and may harm your baby. You should not breastfeed while using Bonjesta®.
It is not known if Bonjesta® is safe and effective in children under 18 years of age.
Bonjesta® is an extended-release formulation, so signs of overdose may not appear right away. If you take too much Bonjesta® (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, urination changes and build-up of fluid in the body. If you have these symptoms and they are severe, they may lead to death. Stop taking Bonjesta®, call your healthcare provider or go to the nearest hospital emergency room right away. If you take too much Bonjesta®, call your poison control center at 1-800-222-1222.
Keep Bonjesta® and all medicines out of the reach of children. Carefully read the storage instruction as detailed in the Bonjesta Patient Information leaflet.
Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please consult full Prescribing Information and Patient Information.
Duchesnay is a specialty pharmaceutical company with a long-standing commitment to women's health. The company focuses on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe and effective for use during pregnancy and breastfeeding. Duchesnay also commercializes a broad portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at various stages of their lives. For more information, visit www.DuchesnayUSA.com.
1 Duchesnay Inc. Bonjesta Full Prescribing Information. Bryn Mawr, PA2017.
2 Whitehead SA, Andrews PLR, Chamberlain GVP. Characterisation of nausea and vomiting in early pregnancy: a survey of 1000 women. J Obstet Gynecol. 1992; 12:364-9
3 Lacroix R, Eason E, Melzack R. Nausea and vomiting during pregnancy: A prospective study of its frequency, intensity, and patterns of change. Am J Obstet Gynecol 2000; 182:931-7.
4 Vellacott ID, Cooke EJA, James CE. Nausea and vomiting in early pregnancy. Int J Gynecol Obstet 1988;27:57-62.
5 Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project (HCUP). Rockville, MD. 2014
6 Attard CL, Kohli MA, Coleman S, et al. The burden of illness of severe nausea and vomiting of pregnancy in the United States. Am J Obstet Gynecol 2002;186:S220-7.
7 Costantine MM, Matok I, Chiossi G, et al. Determinants of Adherence to Delayed-Release Doxylamine and Pyridoxine in Patients With Nausea and Vomiting of Pregnancy. Ther Drug Monit 2012;34(5):569-73.
8 ACOG Practice Bulletin No. 189: Nausea and Vomiting of Pregnancy. Obstet Gynecol. 2018;131(1):e15-30.
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