Is DAYBUE approved outside of the US?
At this time, DAYBUE is only approved in the US for the treatment of Rett syndrome in adults and children 2 years of age and older. If you have a child who is living with Rett syndrome, we understand your urgency to learn what possible treatments may be available for your child. While Acadia Pharmaceuticals Inc. owns the rights to trofinetide in North America (Canada, Mexico and the US), Neuren Pharmaceuticals owns the rights outside of North America.
If you live in the US: DAYBUE was FDA approved on March 10, 2023. By the end of April 2023, DAYBUE will be available by prescription through your doctor. Once you receive your child’s prescription for DAYBUE, you’ll be connected to the dedicated support team at Acadia Connect. The Acadia Connect team will be at your side every step of the way to support you in starting treatment with DAYBUE. You can reach Acadia Connect at 1-844-737-2223.
If you live in Canada: With the US approval complete, we are in the midst of developing a regulatory and commercial plan to commercialize trofinetide in Canada, and will provide further details on the timeline as we progress. For any additional inquiries, please do not hesitate to contact Acadia Medical Information at 1-844-4ACADIA (1-844-422-2342) Option 1 or firstname.lastname@example.org