Allos Pharma, a late-stage pharmaceutical company developing therapeutics for neurodevelopmental disorders, announced they held a meeting with the U.S. Food and Drug Administration (FDA) to optimize the design of their Phase 3 trial. This trial is designed to support a New Drug Application (NDA) to address Fragile X Syndrome.
During the FDA meeting, Allos received invaluable and constructive feedback that is being leveraged with input from the NFXF’s Clinical Trial Committee and will be incorporated into the design of the Phase 3 trial. Allos co-founder Randy Carpenter thanked the FDA for their engagement and guidance and shared that Allos “remain[s] committed to providing a new treatment option for patients and families … and believe that arbaclofen has the potential to make a significant, positive impact on their lives.”
Hilary Rosselot, executive director of the NFXF, shared “The Allos team has made significant progress in developing arbaclofen. The expert clinician members of our Clinical Trial Committee have provided input and guidance to optimize the design of the clinical trial and enthusiastically support performing this study. NFXF looks forward to working in partnership with Allos to better the lives of individuals with Fragile X Syndrome and their families.”
While this does not mean arbaclofen is available for you to use now, this is a big step in the right direction to continue exploring arbaclofen in FXS. Thank you to the amazing families and dedicated professionals who made this possible!
Read the full press release here.
