October 9, 2012 – Results of Type C Guidance Meeting with Food & Drug Administration (FDA) of ZYDIS™ ODT Fluoxetine in the Treatment of Repetitive Behaviors in Autism

Posted by on Oct 9, 2012 in Press Release | 0 comments

Autism Therapeutics announced today that the Type C Guidance Meeting with FDA to discuss the ZYDIS® ODT Fluoxetine / Autism program has taken place. The FDA and Autism Therapeutics discussed the completion of the Phase III development of the program including the use of differentiated doses and strategies to control placebo response. Autism Therapeutics will now be discussing final details of the upcoming pivotal Phase III trial design with FDA under Special Protocol Assessment (SPA). AT Press Release October 9 2012 (FDA Type C Guidance...

read more

March 27, 2012 – Confirmation of Orphan Drug Designation for the Use of Fluoxetine for the Treatment of Autism

Posted by on Mar 27, 2012 in Press Release | 0 comments

Autism Therapeutics announced today that it has received confirmation from the Office of Orphan Drug Products that the Company’s Orphan Drug Designation for the treatment of repetitive behaviors in autism (autistic disorder) remains in good standing. AT Press Release March 27 2012 (ODD Confirmation)

read more

January 18, 2012 – Clinical Trial Services Contract in Rett Syndrome with Neuren Pharmaceuticals Ltd

Posted by on Jan 18, 2012 in Press Release | 0 comments

Autism Therapeutics announced today that In the second half of 2011, Autism Therapeutics Ltd signed a contract with Neuren Pharmaceuticals Ltd. to provide clinical trial services. The Company is supporting Neuren in planned clinical studies of NNZ-2566 in Rett Syndrome, making use of Autism Therapeutics’ experience and expertise in clinical study design and subpopulation/stratification design in developmental disorders. AT Press Release January 18 2012 (Neuren Contract...

read more

January 2, 2012 – Commencement of Autism / Fluoxetine Subpopulation Analysis

Posted by on Jan 2, 2012 in Press Release | 0 comments

Autism Therapeutics announced today that it has commenced an analysis using Personalized Pharmaceutical Systems’ proprietary technology to identify specific subpopulations within the Autism Spectrum Disorders (ASD) population that either have a higher likelihood of exhibiting a positive response to fluoxetine compared to the ASD population as a whole, or have a higher likelihood of exhibiting a placebo response. Upon completion, AT intends to seek approval from FDA to implement a novel clinical trial design for a Phase III clinical trial...

read more

December 21, 2011 – Autism Therapeutics Announces Purchase of Neuropharm Ltd.

Posted by on Dec 21, 2011 in Press Release | 0 comments

Autism Therapeutics announced today the purchase of Neuropharm Ltd. This follows the liquidation of the UK holding of the previously publicly listed company Neuropharm PLC, which occurred in mid 2010. Neuropharm holds intellectual property relating to the ZYDIS™ ODT Fluoxetine / Autism program for autism, which has received Orphan Drug Designation in the U.S. AT Press Release December 21 2011 (Neuropharm...

read more