MorphiDex: Phase III data; NDA under review

ALGO presented updated results from its pivotal clinical trials of MorphiDex (see BioCentury, Sept. 21, 1998).

In a single-dose study of 535 oral surgery patients, MorphiDex produced pain relief superior to morphine alone, dextromethorphan alone and placebo (p<0.05 in all cases). MorphiDex had a pain relief onset of 1.5 hours versus 3 hours for morphine (p<0.05). Similar results were seen in a 301-patient single dose orthopedic surgery trial. ...