FDA on Monday approved a drug to treat the severe nausea and vomiting that some women experience during early pregnancy. Diclegis® (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) is delayed-release tablet intended for women who have not adequately responded to conservative management of nausea and vomiting during pregnancy. According to the reports from sources it is the only FDA-approved treatment for NVP, more commonly known as morning sickness, in more than 30 years.

The two important and active ingredients in the drug that reduce nausea and vomiting in pregnancy – doxylamine succinate and pyridoxine hydrochloride, or vitamin B6, – have been recommended as a first-line pharmacotherapy by the American Congress of Obstetricians and Gynecologists (ACOG) guidelines for the last nine years.

According to the reports the FDA granted Diclegis, a Pregnancy Category A status which means the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.

While briefing news persons and scientists about the approval of the drug Gilbert Godin, Chief Executive Officer, Duchesnay USA said “The FDA approval of Diclegis provides an important new treatment to the millions of pregnant women suffering from morning sickness, and fills a 30 year void in the treatment of NVP”.  He also added that “Duchesnay USA is honored to bring the only FDA-approved treatment to help control symptoms of morning sickness to market. Duchesnay has been dedicated to the health of pregnant women and their unborn children for years and is taking every step to make Diclegis available for women suffering from NVP.”

Diclegis is expected to hit the shelves of the medical stores by the end of May 2013.

About Approval of Diclegis

According to the New Drug Application submitted to the FDA the efficacy and safety of Dicelgis was established on a 15-day randomized, double-blind, placebo controlled and multi-center trial studying pregnant women 18 years of age or older, 7 to 14 weeks gestation, with NVP. According to the study the drug delayed release of doxylamine succinate and pyridoxine hydrochloride  is effective and well tolerated in treating the condition of morning sickness. Reports have also suggested that Diclegis resulted in significantly larger improvement in symptoms of NVP and morning sickness compared with placebo, based on the PUQE score.

Important Safety Information for Diclegis

  • Do not take Diclegis if you are allergic to pyridoxine hydrochloride, doxylamine succinate, other ethanolamine derivative antihistamines, or any of the ingredients in Diclegis.
  • Do not take Diclegis with alcohol or sedating medicine
  • Avoid taking Diclegis in combination with medicines called monoamine oxidase (MAO) inhibitors, as these medicines can intensify and prolong the adverse CNS effects of Diclegis.
  • Diclegis should be used with caution in women who are suffering from any of the below mentioned conditions:

a)  Asthma

b)  Increased pressure in the eye

c)  A stomach problem called stenosing peptic ulcer

d)  An eye problem called narrow angle glaucoma

e)  Pyloroduodenal obstruction

f)   A bladder problem called bladder-neck obstruction.

Signs and Symptoms of Overdose from Diclegis:

  • Restlessness
  • Dilated Pupils
  • Dryness of mouth
  • Sleepiness
  • Vertigo
  • Mental confusion
  • Tachycardia