Posts by AT_Management

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...

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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)

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March 15, 2012 – Closing of Financing for ZYDIS™ ODT Fluoxetine / Autism Program

Posted by on Mar 15, 2012 in Splash Page | 0 comments

Autism Therapeutics announced today that the Company has closed a financing for the ZYDIS™ ODT Fluoxetine / Autism program. AT Press Release March 15 2012 (Closing of Financing)

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A double-blind placebo-controlled trial of fluoxetine for repetitive behaviors and global severity in adult autism spectrum disorders

Posted by on Mar 3, 2012 in Publications | 0 comments

The effects of fluoxetine and placebo on repetitive behaviors and global severity were compared in adults with autism spectrum disorders (ASDs). Adults with ASDs were enrolled in a 12-week double-blind placebo-controlled fluoxetine trial. Thirty-seven were randomly assigned to fluoxetine (N=22) or placebo (N=15). Dosage followed a fixed schedule, starting at 10 mg/day and increasing as tolerated up to 80 mg/day. Repetitive behaviors were measured with the compulsion subscale of the Yale-Brown Obsessive Compulsive Scale; the Clinical Global Impression (CGI) improvement scale was used to rate...

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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...

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