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news.Javelin Pharmaceuticals has completed accrual of subjects in the last of four planned Phase I human pharmacokinetic (PK) studies needed to support its intended filing of a new drug application in 2009, for its intranasal ketamine product candidate, PMI-150.
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This group of four PK studies enrolled a total of 151 subjects, of whom 139 received PMI-150 intranasally, 32 received intravenous ketamine, and 12 received oral ketamine. Some subjects received ketamine by more than one route of administration. No serious adverse events occurred in any of the four trials.
Javelin believes that PMI-150 is optimized for use as a pain medication and may offer a safe, non-opioid alternative for the treatment of acute moderate-to-severe pain. The company is planning a pivotal Phase III postoperative acute pain study for this product candidate.
Curtis Wright, executive vice president for Risk Management and Regulatory Affairs at Javelin, said: “This group of four PK studies addressed the multiple dose kinetics, the effects of common nasal decongestants and allergy medications, and the relative contributions of nasal and oral absorption to the bioavailability of PMI-150.”