October 20, 2005
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Nasally delivered morphine showing efficacy against postop pain

Patients treated with the highest intranasal morphine doses in a phase 2b study experienced pain relief similar to standard intravenous morphine.

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A new nasally administered morphine formulation is showing efficacy for relieving postoperative pain in orthopedic surgery patients.

Javelin Pharmaceuticals Inc. — formerly Innovative Drug Delivery Systems — announced that Rylomine (intranasal morphine) met the primary endpoint in a phase 2b study. The drug induced a linear dose response, relieving patients’ Visual Analog Scale-measured pain over four hours, according to a company press release.

Although it is the standard of care for acute pain, including postoperative pain, morphine is poorly absorbed across mucosal barriers, particularly the nasal membrane. The morphine formulation used in Rylomine uses a carbohydrate polymer that the company calls ChiSys, which enhances the absorption of compounds across mucosal membranes, allowing predictable therapeutic blood levels of morphine to be delivered nasally, according to the press release.

In the study, termed MOR-002, researchers randomly assigned 187 patients with moderate-to-severe pain following bunionectomy to one of three groups. In the single dose phase, patients received either a single bolus intravenous injection of morphine 7.5 mg, one of four varying intranasal doses of Rylomine (from 3.75 mg to 30 mg), or placebo. After the single dose phase, patients received multiple doses of either Rylomine 7.5 mg or 15 mg over 24 hours.

Both patients and study investigators were blinded to the treatments, company officials noted in the press release.

Patients who received a single dose of either Rylomine or intravenous morphine experienced statistically significant pain relief over four hours compared to placebo-treated patients. Additionally, at its highest intranasal doses, Rylomine caused analgesic effects similar to intravenous morphine.

Investigators reported no serious drug-related adverse events. Local adverse events associated with nasal administration of the drug were more common in the intranasal morphine group and included bad taste, nasal congestion, throat irritation and sneezing.

Other general adverse events, such as dizziness, nausea, sedation and vomiting, were related to morphine itself regardless of the administration method and were consistent with morphine's pharmacologic effects.

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