Huntington’s Disease: Auspex Pharmaceuticals Gets FDA Orphan Drug Designation
Auspex Pharmaceuticals, a La Jolla, California-based biopharmaceutical company focusing on developing and commercializing medicines for rare diseases, announces November 6th, that the FDA grants Orphan Drug Designation (ODD) for investigational compound SD-809 for Huntington’s Disease (HD).
The following are clinical trials for SD-809:
• Phase III registration clinical trial (First-HD) that is evaluating the efficacy and safety for treatment of chorea (abnormal involuntary movements) associated with HD – “on track to announce topline data in December 2014”
• Phase III open-label switch & long-term safety (ARC-HD).
The following are planned clinical trials for SD-809 for additional orphan hyperkinetic movement disorder indications:
• Phase II/III for drug-induced tardive dyskinesia
• Phase Ib for Tourette Syndrome.
FDA Orphan Drug Designation Database Record For Auspex Pharmaceuticals
|Generic Name:||d6-tetrabenazine, deutetrabenazine|
|Orphan Designation:||Treatment of Huntington’s Disease|
|Orphan Designation Status:||Designated|
|FDA Orphan Approval Status:||Not FDA Approved for Orphan Indication|
|Sponsor:||Auspex Pharmaceuticals, Inc. 3366 N. Torrey Pines Court Suite 225 La Jolla, CA 92037|
This is the 4th FDA ODD for Huntington’s Disease in 2014:
2014 FDA ODDs For Huntington’s Disease
|#||Generic Name||Sponsor Company||ODD Date|
|1||2-[4-(1-Methyl-4-pyridin-4-yl-lH-pyrazol-3-yl)-phenoxymethyl]-quinoline succinic acid||Pfizer||06.02.14|
|2||Carbenoxolone||Oxalys Pharmaceuticals (Canada)||07.02.14|
|3||5,7-dichloro-2-methylaminomethyl-8-hydroxyquinolone hydrochloride||Prana Biotechnology (Australia)||09.04.14|
|4||d6-tetrabenazine, deutetrabenazine||Auspex Pharmaceuticals||11.05.14|
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