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| | | ![]() Intranasal Morphine Equivalent to IV Formulation: Presented at AAP By Crystal Phend SAN DIEGO, C.A. -- February 27, 2006 -- An intranasal formulation of morphine (MNS075, Rylomine) appears to be as safe and effective as a similar dose of intravenous morphine in counteracting postsurgical pain, researchers said here at the annual meeting of the American Academy of Pain Medicine (AAP). "This way of giving morphine without a needle seems to do everything morphine with a needle does," said presenting author Daniel B. Carr, MD, Chief Medical Officer, Javelin Pharmaceuticals, Cambridge, Massachusetts, United States, during a presentation on February 23rd. Dr. Carr said the advantages of a nasal spray form are that it is intuitive for patients to use, noninvasive, and does not require expensive patient controlled analgesia equipment. Patients were randomized to receive a single dose of 3.75 mg, 7.5 mg, 15 mg, or 30 mg of intranasal morphine, 7.5 mg IV morphine or placebo during the first 30 minutes after bunionectomy surgery with or without ipsilateral hammertoe repair. All 187 patients were also randomized to receive either 7.5 mg or 15 mg doses of intranasal morphine as rescue medication in the 24 hours after the first morphine dose. All medication doses were superior to placebo in relieving pain, Dr. Carr said. The lowest effective intranasal dose was 7.5 mg. Four hour total pain relief scores indicated that 7.5 mg of intranasal morphine is approximately as potent as 5 mg of IV morphine. Both the 7.5 mg and 15 mg rescue doses of intranasal morphine were effective. The higher dose was more effective but the lower dose was better tolerated, Dr. Carr said. No serious adverse events were reported for the study drug, although most patients experienced mild to moderate adverse events in both phases of the study. In both treatment groups, 10% of patients experienced local adverse events. For the nasal solution these were most commonly bad taste, nasal congestion, nasal discomfort, throat irritation, sneezing and rhinorrhoea. Dr. Carr said the intranasal formulation reaches peak efficacy about 20 minutes after administration, so it may not be as prone to abuse as some faster acting opioids. The ingredient that allows the morphine to stay in contact with the nasal passage long enough to be absorbed is made from shellfish. He said the researchers are currently excluding patients with shellfish allergy. Dr. Carr said the new formulation appears to be a simple, reliable substitute for IV morphine.
[Presentation title: Rylomine (Intranasal Morphine), a Non-Invasive Alternative to Injectable Morphine: Characterization of Analgesic Properties and Side Effects in Moderate-to-Severe Postsurgical Pain. Poster 141]
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