Diclegis® (Doxylamine Succinate and Pyridoxine Hydrochloride) for Morning Sickness Preferred Through Indiana, Colorado and Nevada Medicaid Programs

ROSEMONT, Pa., Jan. 05, 2016 (GLOBE NEWSWIRE) -- Duchesnay USA today announced that Diclegis® delayed-release tablets, for the treatment of Nausea and Vomiting of Pregnancy (NVP) in women who do not respond to conservative management,1 are on the preferred drug list under the Indiana, Colorado and Nevada state-administered Medicaid programs.

NVP (commonly called morning sickness) is a very common medical condition, which is experienced by 70% to 85% of pregnant women. NVP can be quite debilitating throughout a woman’s pregnancy; however, treatment with Diclegis® can help reduce NVP symptoms.

The addition of the Indiana, Colorado and Nevada Medicaid programs further expands availability to the already numerous commercially insured consumers that can currently access Diclegis®. These three states join a growing list of influential State Medicaid programs, including California, Connecticut, Tennessee, Texas and Wisconsin, which cover Diclegis® without special authorization requirements. Now, even more women across the country suffering from NVP will be able to receive Diclegis® under state-administered Medicaid programs.

Diclegis® is the only FDA-approved medicine for NVP and is safe and effective.1 The FDA granted Diclegis® Pregnancy Category A status1, the best rating available.2

For more information about Diclegis®, visit www.Diclegis.com.

Indication

Diclegis 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

Diclegis has not been studied in women with hyperemesis gravidarum.

Important Safety Information

Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse central nervous system (CNS) effects of Diclegis.

The most common side effect of Diclegis is drowsiness. Do not drive, operate heavy machinery, or 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 Diclegis. Severe drowsiness can happen or become worse causing falls or accidents.

Diclegis should be used with caution in women who have certain medical conditions, such as asthma (1), or eye (2, 3), stomach (4, 5, 6) or bladder problems. Tell your healthcare provider about all of your medical conditions so he/she can assess if Diclegis is right for you.

It is not known if Diclegis is safe and effective in children under 18 years of age. Keep Diclegis and all medicines out of the reach of children.

Diclegis is a delayed-release formulation, so signs of overdose may not appear right away. If you take too much DICLEGIS (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, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking DICLEGIS, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.

Diclegis is intended for use in pregnant women.

Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional important safety information, please see full Prescribing and Patient Information at www.diclegis.com. This information is not intended to replace discussions with your healthcare provider.

About Nausea and Vomiting of Pregnancy (NVP)

Nausea and vomiting of pregnancy (NVP), or morning sickness, affects 70 to 85 percent of pregnant women.3,4,5,6 NVP can present differently for each woman, the symptoms include: nausea, gagging, retching, dry heaving, vomiting, and odor and/or food aversion.7 For most pregnant women, symptoms generally cease at approximately 16 to 20 weeks.6 However, some women can experience symptoms throughout their pregnancy.8

About Diclegis

Diclegis (doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg) delayed-release tablets are the only FDA-approved prescription treatment for nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.1 Diclegis has proven to be a safe and effective treatment option for NVP and received Pregnancy Category A status, which means the results of controlled studies have not shown an increased risk to an unborn baby.1,2

About Duchesnay USA

Duchesnay USA is a unique healthcare company devoted to safeguarding the health and well- being of expectant mothers and their unborn babies. Its affiliate company, Duchesnay Inc., was founded in 1970 in Canada. The family-owned company realigned its business in 1992 to focus specifically on pregnant women after a family member experienced a very difficult pregnancy. Duchesnay’s mission is to develop pharmacological solutions to reduce the symptoms of nausea and vomiting during pregnancy (NVP). Duchesnay USA was established in Rosemont, Pennsylvania in 2011 to pursue that same mission. Realizing a lack of sufficient information on medications for use in pregnancy, Duchesnay strives today to ensure that expectant women who require pharmacological treatments have access to proper medical advice and therapies that are safe for them and their unborn babies. For more information on Duchesnay USA, please visit www.DuchesnayUSA.com.

1 Diclegis Prescribing Information. Duchesnay USA. 2013.
2 Department of Health and Human Services, Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Federal Register. 2008; 73 (104):30831-68.
3 Jewell, D, Young, G. Interventions for Nausea and Vomiting in Early Pregnancy. The Cochrane Library. 2002; 1.
4 Medalie, J. Relationship between Nausea and Vomiting in Early Pregnancy and/or Abortion. The Lancet. 1957; 117-119.
5 Whitehead, SA, Andrews, LR, Chamberlain, VP. Characterisation of Nausea and Vomiting in Early Pregnancy: A Survey of 1000 Women. Journal of Obstetrics and Gynaecology. 1992; 12: 384-369.
6 Gadsby, R, Barnie-Adshead, A, Jagger, C. A Prospective Study of Nausea and Vomiting During Pregnancy. British Journal of General Practice. 1993; 43: 245-248.
7 Clark S, Costantine M, Hankins GDV. Review of NVP and HG and early pharmacotherapeutic Intervention. Obstetrics and Gynecology International Volume. 2012.
8 Jarnfelt-Samsioe, A, Samsio, G, Velinder, G. Nausea and Vomiting in Pregnancy – A Contribution to Its Epidemiology. Gynecologic and Obstetric Investigation. 1983; 16: 221-229.

Contact Chantal Beaudry Lazar Partners cbeaudry@lazarpartners.com (212) 867-1762

Source:Duchesnay USA