AP Pharma Reports Experimental CINV Treatment Fails to Show Superiority

A.P. Pharma Inc reported that in a late-stage study, its experimental treatment in the 5 mg dose for chemotherapy induced nausea and vomiting (CINV) failed to meet a superiority goal over Eisai´s Aloxi, which is already indicated for the treatment of CINV, in four different assessments.

The trial was comparing the efficacy of 5 mg and 10 mg doses of APF530 (generically granisetron).

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 10 mg dose appeared to provide greater efficacy with a side-effect profile similar to the 5 mg dose, the company said. As such, the 10 mg dose will be the proposed dose included in the new drug application.

If eventually approved, APF530 would be competing with Aloxi, as well as with Merck & Co´s Emend ($ 125 million dollars in 1H 2008) and GlaxoSmithKline´s Zofran ($ 119 million dollars in 1H2008).