Below is the update on domperidone in the US provided by the US Lactation Consultant Association. Please feel free to contact me if there are any questions.


Marsha Walker, RN, IBCLC
Weston, MA


United States Lactation Consultant Association Announces

 
September 09, 2011 
 
Orphan drug designation obtained for Domerpidone in the US
 
Over the last few months, USLCA has been working in conjunction with Dr. Thomas Hale from the Infant Risk Center at Texas Tech University towards obtaining approval from the Food and Drug Administration (FDA) for the use of Domperidone for breastfeeding mothers experiencing insufficient breastmilk. Clinicians in the US have long been unable to (or only with difficulty) offer this option to selected mothers experiencing insufficient milk production. The first step in this process was to obtain orphan drug status for Domperidone. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The approval of an orphan designation does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and efficacy must still be established through adequate and well controlled studies, but the orphan status qualifies for grants to conduct such studies. The FDA granted orphan drug status to domperidone for "treatment of hypoprolactinemia in breastfeeding mothers, and in some hypoprolactinemic conditions follwing the use of cabergoline or bromocriptine in mothers who wish to return to breastfeeding."  Once the required studies are conducted, they are submitted to the FDA for final marketing approval. USLCA and Dr. Hale are beginning work on the next stage of this process which is to apply for grants to conduct the FDA required clinical trials with the hope of eventually obtaining marketing approval for Domperidone. Dr. Hale has been instrumental in collecting the required information and filing the application for orphan drug status. His intense work and command of the subject were invaluable in making it this far. While the process for FDA approval of the use of Domperidone is a lengthy one, we are well on our way to hopefully being able to provide this option for the mothers who may need it so desperately.   
 
 







 

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