Javelin Treats First Patient in Phase III Pain Study
Posted on: Wednesday, 24 May 2006, 21:00 CDT
Javelin Pharmaceuticals has treated the first patient in a phase III clinical study of Rylomine, the company's proprietary intranasal formulation of morphine.
Rylomine is a patient-controlled nasal spray that delivers a single, metered dose of morphine, an opioid analgesic used for the treatment of moderate-to-severe pain. After use, a negligible amount of morphine remains in the dispenser, avoiding the risk of scavenging and abuse of discarded devices.
The pivotal phase III study will enroll 256 patients with moderate-to-severe postoperative orthopedic pain. These patients will be randomized to receive one of two dosing regimens of Rylomine, intravenous morphine, or placebo.
This study follows Javelin's successful completion of a 187-patient phase IIb study in patients with acute postoperative pain, and the company's successful end-of-phase II meeting with the FDA.
Results from the phase IIb study were presented at annual meetings of the American Academy of Pain Medicine in February and the American Pain Society in May. These results showed that Rylomine provided postsurgical patients with clinically and statistically significant relief of postoperative orthopedic pain, similar to intravenous morphine.
Source: Datamonitor
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