NDA for Transdermal Patch Formulation of Asenapine Submitted to FDA

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An NDA has been submitted to the FDA for a transdermal patch formulation of asenapine for the treatment of schizophrenia.
An NDA has been submitted to the FDA for a transdermal patch formulation of asenapine for the treatment of schizophrenia.

A New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) for a transdermal patch formulation of asenapine for the treatment of schizophrenia. HP-3070 is being developed by Hisamitsu Pharmaceuticals in Japan in conjunction with its US subsidiary, Noven Pharmaceuticals. 

Results from a Phase 3 study evaluating the safety and efficacy of HP-3070 (N=617) showed that the treatment was associated with statistically significant improvement from baseline in the change of the total Positive and Negative Symptom Scale (PANSS) score at 6 weeks when compared with placebo. The most common adverse reactions associated with treatment included application site reaction, headache, and extrapyramidal disorder.

Asenapine is an atypical antipsychotic currently available as a sublingual tablet under the brand name Saphris (Allergan). 

For more information visit Noven.com.

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