Press release
ANAVEX®2-73 (blarcamesine) Receives Compassionate Use Authorization for Pediatric Patients with Rett Syndrome
Health Canada Special Access Program (SAP) Authorizes ANAVEX®2-73 (blarcamesine) for patients after successful completion of Open-Label Extension (OLE) study
About this update from Anavex Life Sciences Corp.
[{"type":"text","content":"Health Canada Special Access Program (SAP) Authorizes ANAVEX®2-73 (blarcamesine) for patients after successful completion of Open-Label Extension (OLE) study Granting of requests are also ongoing in United Kingdom and Australia – representing all regions of Rett Syndrome study participation NEW YORK, June 15, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the first patients with Rett syndrome from the ANAVEX®2-73-RS-003 study (EXCELLENCE) are able to continue treatment with ANAVEX®2-73 (blarcamesine) thanks to Health Canada’s approval of the Special Access Program (SAP), allowing for compassionate use following completion of the 48-week Open-Label Extension study. Special Access Program (SAP) applications are granted at a physicians’ request on behalf of patients. Based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that the study drug will continue to benefit patients, Anavex will continue its responsibility to support patients post study by facilitating the supply of ANAVEX®2-73 (blarcamesine) to patients in Canada. Approved compassionate programs are also ongoing in the United Kingdom and Australia, representing all regions of the Rett Syndrome study participation. “Today there is no specific treatment for Rett syndrome available in Canada and the Ontario Rett Syndrome Association (O.R.S.A.) is pleased to see Health Canada has just granted several investigators’ requests to access for this study drug that may be beneficial to their patients,” commented Sabrina Millson, President of the Ontario Rett Syndrome Association. Health Canada's Special Access Program (SAP) for drugs enables drugs that are not marketed in Canada to be requested by practitioners for the treatment, diagnosis, or prevention of serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or are unavailable either as marketed products, or through enrollment in clinical trials.1 Christopher U Missling, PhD, President and Chief Executive Officer of Anavex sa...