Enforcement Discretion for Investigational FMT Extended for Severe and Fulminant CDI

We are pleased to share that the FDA has agreed to permit OpenBiome to continue distributing investigational FMT under enforcement discretion for patients with severe and fulminant C. difficile infection (CDI), including pediatric cases. This temporary continuation is valid until December 31st, 2024, or until our IND Phase 2 protocol is cleared to proceed.

On Monday, November 4th, we will pause order processing and shipping to update our systems for ordering investigational FMT to reflect the guidance we received from the FDA. We will accept orders for severe and fulminant CDI beginning Tuesday, November 5th. Until then, if you have emergency severe or fulminant CDI cases, please contact our Clinical Outreach team at info@openbiome.org.

Consistent with our September 20th notice, enforcement discretion will not be extended for CDI that is not severe or fulminant. We will require physicians to confirm that any requested FMT preparations are to treat confirmed cases of severe or fulminant CDI.

We are thankful to the FDA for listening to the patient and clinician communities and prevailing evidence and making this decision to prioritize patient care. As part of this guidance, we are submitting an IND application to the FDA by November 30th. We will update you, our clinical network, on this submission as it progresses. If you are a clinician and wish to support OpenBiome’s IND application, please contact our Chief Medical Officer, Dr. Majdi Osman, at science@openbiome.org.

Our commitment to leaving no C. diff patients behind is unwavering, and we appreciate your ongoing support for continued access to investigational FMT for those in greatest need.

Frequently Asked Questions

What is the current policy for ordering investigational FMT from OpenBiome?

Through December 31st, 2024, OpenBiome will continue to distribute FMT for patients with severe/fulminant C. difficile only. Enforcement discretion has not been extended for other forms of C. difficile.

If you have a patient suffering from severe/fulminant C. difficile, you can download an order form from our website and submit it to info@openbiome.org.

If patients with severe/fulminant CDI require repeat dosing, please use the Repeat Dose Order Form to request additional material.

Please note: Only the initial dose will be our liquid formulation MTP-101LF. Any repeat doses will be our encapsulated formulation, MTP-101-C. Exceptions will be considered for patients who are unable to tolerate or swallow capsules.

How can we obtain investigational FMT from OpenBiome after December 31st?

We are submitting an IND to the FDA to investigate the safety and efficacy of FMT in patient groups (fulminant, pediatric) that do not currently have approved products available to them. If you are interested in participating as a potential trial site, please reach out to science@openbiome.org.
We are refining a process to help physicians expediently submit single-patient and emergency single-patient INDs. In the meantime, you may review the FDA’s instructions for applying for both emergency and non-emergency single-patient INDs here.