In France, the product is part of a compassionate use program administered by the ANSM, within a strictly regulated and non-commercial framework, in accordance with the regulations applicable to health products currently in development.

For more information, visit the ANSM website

Expanded Access Policy (United States)

OT4B is committed to developing a safe and efficacious therapy for the treatment of Prader-Willi. It is through formal clinical studies that data is generated to assess the investigational product in order to fully understand the ability these products have to treat the disease while still controlling for patient safety, allowing for a thorough regulatory review and future approval by Regulatory Authorities.

We understand that not all patients are eligible for clinical programs, and these patients and families are interested in having access to the investigational product prior to regulatory approval through participation in an Expanded Access Program. Unfortunately at this time, OT4B is not able to offer expanded access use of our investigational medicine. OT4B may revise this expanded access policy and amend it as appropriate.