CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals, Inc. today announced that following peer review, its paper “Safety and Efficacy of Intranasal Ketamine for Acute Pain” was published in “Acute Pain” the International Journal of Acute Pain Management. This journal is the official journal of the Special Interest Group on Acute Pain, of the International Association for the Study of Pain – a leading worldwide scientific and professional organization in the field. This Phase 2 study tested 10-30 mg doses of intranasal ketamine in a well-accepted model of acute postoperative pain, molar extraction. Consistent with the Company’s prior studies of intranasal ketamine, patients reported rapid (less than 10 minutes) onset of pain relief, generally mild and transient adverse effects, and had no changes in vital signs, oxygen saturation or the nasal mucosa, and no significant dissociative psychological effects. Integrated pain relief scores over 1 and 3 hours after drug dosing were significantly better for ketamine than placebo (P = 0.013 and 0.028, respectively). Pain relief with the highest ketamine dose (50 mg) separated from placebo over 1 hour (P less than 0.01) as well as over 3 hours, over which time the lowest dose was also superior to placebo (P less than 0.05 for both. The paper concluded that intranasal ketamine may offer a safe, nonopiod, patient friendly and needle-free analgesic with efficacy in moderate-to-severe pain. A pivotal Phase 3 study is being planned to facilitate filing a New Drug Application for the treatment of acute moderate-to severe pain. In addition, a Phase 3, multicenter trial of intranasal Ketamine (PMI-150) for breakthrough cancer pain is currently underway and accruing patients.
