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news.Javelin Pharmaceuticals has announced that it will present encouraging results of a new Phase I study of pain drug Dyloject demonstrating minimal effects upon platelet function at a clinically effective dose. In contrast, aspirin and ketorolac each impaired platelet aggregation significantly.
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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. In this single center, open-label, crossover study, 30 normal healthy male volunteers were randomized to receive a single bolus intravenous injection of Dyloject 75mg, an oral dose of Cataflam 50mg, an intravenous dose of ketorolac tromethamine 30mg and an oral dose of aspirin 325mg.
Daniel Carr, Javelin’s CEO/CMO, said: “These results are consistent with our earlier observations of less surgical site bleeding with Dyloject than ketorolac at clinically pertinent doses. 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.”