Freedom of Information request (FOI 22/837)
Published 17 January 2024
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19th October 2022
FOI 22/837
Dear
Thank you for your email.
Please accept our apologies for the delay in a response.
On 25th June we received your request under the Freedom of Information act:
“the trials carried out on the drug Debendox and the safety test of Debendox in pregnant woman and the effects if any once the cold was born.in particular Dicyclomine and Doxylamine in combination by Merrell Dow pharmaceutical Inc.
Also the toxicity/teratogenicity if Dicyclomine and Doxylamine in combination.”
With regard to trial data, Debendox was on the market at the time that the Medicines Act of 1968 was implemented. It was therefore granted a product licence of right (PLR) and the evidence of effectiveness will have been subject to review at a later date. We have not been able to identify from our archive records information that would fulfil your request for trial data for Debendox.
Debendox was initially available as a triple combination product (doxylamine, pyridoxine, dicyclomine) and subsequently reformulated to a dual combination product (doxylamine, pyridoxine). Doxylamine succinate 10mg, pyridoxine hydrochloride 10mg is currently authorised as the combination product Xonvea (PL 44081/0006) for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management (i.e. changes in diet or other non-medicine treatments). A summary of the evidence considered at the time of granting the licence for Xonvea is attached and is available at the link below.
https://mhraproducts4853.blob.core.windows.net/docs/dad564236129d859aad6832f2fc118cbb7642c4e
We have not identified data in our archive records regarding non-clinical toxicity and teratogenicity testing of dicyclomine and doxylamine in combination.
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Yours sincerely
MHRA Customer Experience Centre