Since December 2021, in France, neonates and infants under six months old with Prader-Willi syndrome can be given oxytocin treatment for a duration of eight weeks.

This treatment can be initiated after obtaining a favourable opinion in a Multidisciplinary Consultation Meeting and authorisation from the ANSM (French National Agency for the Safety of Medicines) has been obtained by the doctor.

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.