Domperidone and Orphan Drug Status

[Edith Davidson]

I saw the announcement by Dr Hale and USLCA of the orphan drug status of Domeridone being approved by the FDA (on Facebook), but I can't find documentation anywhere else. The FDA website doesn't have anything I can find, and it is not on the USLCA website either.

Is there something I can show the doctors about this so they will feel comfortable prescribing it for their patients??

Edith Davidson RN IBCLC
Pennsylvania

[admin]

Edith:

I was notified last week by the FDA, Division of Orphan Drugs, that I had received designation of domperidone as an orphan drug for the treatment of hypoprolactinemia in breastfeeding mothers. According to them, it will take about a month to get on their website.

Please be advised that this is only the first step. We must now go through the standard New Drug Application to the FDA, so we are probably years away from approval. But its a great starting place.


Tom Hale Ph.D.

[Ingrid]

IND participation needed to write a script for Domperidone?

I saw a mother this week with low milk volume who had failed to respond to Fenugreek, Reglan and various other galactogogue combo herbals ( motherlove more milk, goats rue, blessed thistle, etc). Her OB and I discussed other options. I mentioned Domperidone and the doctor stated it would be illegal for him to write a script since this drug had been pulled by the FDA. I explained the orphan drug status designation as of October of 2011 but we couldn't find anything on the FDA website and the Oklahoma Licensure Board had a blurb from Spring 2009 that anyone writing a script for it could be subject to action against their license for writing an illegal script unless they wrote it as part of an IND study or in an emergency for gastroparesis.

Is this true or does orphan status change the legal issues with writing a script? If an IND study is required, I'm guessing you are doing one, can I get my institution on board to be part of your IND?

Your last post stated the FDA would put something up in a month or so but I still don't find anything. Any help or a point in the right direction would be appreciated.

Ingrid Dixon, LPN, IBCLC
Oklahoma City

[admin]

Ingrid:

While I presently have an Orphan designation for domperidone, this does not at all mean it is approved by the FDA for marketing. Its just a first step in this onerous process. So it is NOT available in the USA at present.

That said, if Reglan did not work, it is not likely domperidone will either. Both work exactly the same, to release prolactin into he mothers plasma.

If Reglan did not work, I would suspect insufficient glandular tissue.

Sorry.

Tom Hale Ph.D.

[kay.mckee]

So what, exactly, does "orphan drug" status do for us in the US re domperidone for use in BF mothers? I have providers willing to script it based on the literature, particularly since everyone is so freaked over risks with reglan (with no thought to how we use it, vs. typical use). I have not found pharmacies willing to fill those scripts though. Is orphan drug status for a particular use (hypoprolactinemia) an ok for a US pharmacist to fill for that use?

[admin]

kay:

No. Orphan status only means I have the privilege of presenting a New Drug Application to the FDA. It MUST be first approved by the FDA before any drug can be sold in the USA. I'm a long way from approval.

Tom Hale PH.d.

[kay.mckee]

domperidone and the FDA

Is there any way those of us in the trenches can assist with the process of getting domperidone through the FDA's process? Also, I understand that Dr. Frank Nice is now part of the FDA; is he in a position to help you and us and all the BF moms who would benefit?

[admin]

Kay

There is nothing you can do right now. I'm going Washington later this month to find out more about the process.

Thanks for the thought.

Tom Hale

[harry045]

I have providers willing to script it based on the literature, particularly since everyone is so freaked over risks with reglan (with no thought to how we use it, vs. typical use). I have not found pharmacies willing to fill those scripts though. Is orphan drug status for a particular use (hypoprolactinemia) an ok for a US pharmacist to fill for that use?

[harry045]

but I can't find documentation anywhere else. The FDA website doesn't have anything I can find, and it is not on the USLCA website either.

Is there something I can show the doctors about this so they will feel comfortable prescribing it for their patients??

[harry045]

but I can't find documentation anywhere else. The FDA website doesn't have anything I can find, and it is not on the USLCA website either.

Is there something I can show the doctors about this so they will feel comfortable prescribing it for their patients??