NDA for Transdermal Patch Formulation of Asenapine Submitted to FDA
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.