July 9, 2013
/PRNewswire/ -- Duchesnay
today announced that Diclegis® (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP), more commonly known as morning sickness, is now available for coverage under the state and federal Medicaid program effective
July 1st, 2013
represented the mandatory effective date for state coverage following the execution of a rebate agreement with the Center for Medicare and Medicaid Services (CMS) after the FDA approval of Diclegis on
Coverage by Medicaid of Diclegis, the only FDA-approved NVP treatment, complements the numerous commercially insured lives that can currently access the treatment as well. Diclegis is also the only FDA Pregnancy Category A product available to pregnant women in the U.S.
"Having an FDA-approved treatment for nausea and vomiting of pregnancy, or morning sickness, that is safe and effective was just half of the battle," said
Gary Hankins, MD, Jennie Sealy Smith Distinguished Professor and Chairman, University of Texas Medical Branch, Department of Obstetrics and Gynecology.
"Making it accessible to almost every woman who might need the treatment will finally help fulfill a significant unmet need to the millions of women suffering from NVP."
The Medicaid Drug Rebate Program is a partnership between CMS, state Medicaid agencies, and participating drug manufacturers that helps to offset the federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. All 50 states and the
District of Columbia
cover prescription drugs under the Medicaid Drug Rebate Program.
"We believe that women ought to have the option to treat conditions that truly impact them, and Diclegis is the only FDA-approved Pregnancy Category A treatment for NVP," said
Gilbert Godin, Chief Executive Officer, Duchesnay USA
. "It has been Duchesnay
critical focus to make Diclegis, affordable, accessible and broadly available. With Medicaid eligibility, we can help ensure that women of all backgrounds can access this one-of-a-kind safe and effective therapy."
For more information about Diclegis, visit
. For more information about Medicaid prescription drug benefits, visit:
Important Safety Information for Diclegis
Diclegis® is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
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 (MAO) inhibitors, as these medicines can intensify and prolong the adverse CNS effects of Diclegis. Use of MAOs may also prolong and intensify the anticholinergic (drying) effects of antihistamines.
The most common side effect of Diclegis is drowsiness. You should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis until cleared to do so by your healthcare provider.