UPDATE 1-A.P. Pharma drug fails to meet superiority goal

Tue Sep 30, 2008 7:19am EDT
 
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Sept 30 (Reuters) - A.P. Pharma Inc (APPA.O) said its experimental treatment for chemotherapy induced nausea and vomiting (CINV) failed to meet a superiority goal of a late-stage study.

The trial was comparing the efficacy of 5mg and 10mg doses of APF530, or granisetron, with Aloxi, which is already indicated for the treatment of CINV, in four different assessments.

The company said the drug met the main goal of being comparable to Aloxi in three assessments, but failed to prove its superiority over the comparable drug for the highly emetogenic (vomit-inducing) delayed onset assessment.

The company also noted one serious adverse event possibly related to the drug during the trial.

However, the 10mg dose appeared to provide greater efficacy with a side-effect profile similar to the 5mg dose, the company said. As such, the 10mg dose will be the proposed dose included in the new drug application, it added. Shares of the company, which have lost nearly 44 percent of their value over the last 12 months, closed at $1.15 Monday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Anil D'Silva)

 

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