News: Javelin Pharmaceuticals' Latest Study of Dyloject(TM) …
Javelin Pharmaceuticals Inc. (AMEX: JAV) today will present
results of a new Phase I study of Dyloject(TM) (injectable diclofenac
sodium) demonstrating minimal effects upon platelet function at a
clinically effective dose. In contrast, aspirin and ketorolac each
impaired platelet aggregation significantly. Inhibition of platelet
aggregation with Dyloject and another comparator, Cataflam (an oral
formulation of diclofenac) was detectable but not clearly outside the
normal range, although Cataflam inhibited platelet aggregation
slightly more than Dyloject. These findings will be presented by
Javelin’s CEO/CMO Dr. Daniel Carr as part of a broader corporate
update about Javelin at the 26th Annual JPMorgan Healthcare Conference
in San Francisco.
“These results are consistent with our earlier observations of
less surgical site bleeding with Dyloject than ketorolac at clinically
pertinent doses,” said Dr. Carr. “This commercially relevant data
further demonstrates what we believe are the comparative advantages of
Dyloject over ketorolac, the only approved injectable NSAID in the US
market.”
About the Study
In this single center, open-label, crossover study, 30 normal
healthy male volunteers were randomized to receive a single bolus
intravenous injection of Dyloject(TM) 75 mg, an oral dose of Cataflam
50 mg, an intravenous dose of ketorolac tromethamine 30 mg, and an
oral dose of aspirin 325 mg. In this “unblinded” study, patients
received all four identical treatments the identity of which was known
by the investigator and the patient.
Platelet function was assessed at multiple time points up to 24
hours following exposure to each of the test drugs. The primary
observations were the times (in seconds) to formation of a platelet
plug upon exposure to either collagenADP or collagenepinephrine, as
measured in standard fashion using the PFA-100 platelet analyzer.
The study demonstrated marked, prolonged alterations in platelet
function after both ketorolac and aspirin, with highly statistically
significant alterations in PFA-100 results noted for both
collagenepinephrine and collagenADP induced aggregation. In
contrast, the effects of Dyloject and Cataflam, although discernible,
achieved a maximum magnitude comparable to the upper range of normal.
There were no serious or significant adverse events and the most
common side effects reported, regardless of treatment group, were
flatulence (13%), and headache (
