Orthopedic Surgery

October 23, 2006

YM Biosciences issued positive interim results from a phase IIb trial of AeroLEF, an inhaled therapy for the treatment of acute post-surgical pain. This randomized, double-blind, placebo-controlled trial enrolled 21 subjects who self-titrated AeroLEF in an effort to match dosage to individual pain intensity. Treatment was shown to be well tolerated with all adverse events mild in severity. Efficacy results demonstrated that patient self-titrated dosing with AeroLEF provided clinically meaningful analgesia in 81%, 100% and 87.5% of treated pain episodes during doses 1, 2 and 3 respectively. Reduction in pain intensity was reported within the first 10 minutes of initiation of treatment in 38%, 73% and 63% of the subjects during doses 1, 2 and 3 respectively. Part II of this trial is currently underway. It is designed to compare the safety and efficacy of AeroLEF versus placebo for management of pain following elective orthopedic surgery.

October 17, 2005

Javelin Pharmaceuticals issued positive results of a phase IIb trial, dubbed MOR-002, of Rylomine, their intranasal morphine drug for the treatment of pain following orthopedic surgery. Trial data established linear dose-response in the primary efficacy measure, change in pain severity on the Visual Analog scale at 4 hours post dosing. Efficacy was comparable to intravenous morphine. This multi-center, double- blind, two-stage, randomized, placebo- and active- controlled study enrolled 187 bunionectomy patients, who received single doses one of four doses of Rylomine (3.75 mg to 30 mg), a bolus injection of morphine (7.5 mg), or placebo, followed by a multiple dose stage where subjects received one of two doses of the drug (7.5 mg or 15 mg) over 24 hours.

September 9, 2002

Results of the Penthifra Plus study involving 656 subjects undergoing surgery for hip fracture showed that Arixtra (fondaparinux) administered for four weeks significantly reduces the incidence of deep venous thrombosis (DVT), compared to Arixtra administered for one week. In the double-blind, placebo-controlled study, subjects were all given 2.5 mg Arixtra for seven days following surgery for hip fracture. On day seven, subjects were randomized into two groups, and for the remaining 21 days of treatment they either continued being given the study drug or were given placebo. At the end of the treatment period, the incidence of thromboembolic complications was 1.4% for the Arixtra group compared to 35% for the placebo group. This study of Arixtra was sponsored by Sanofi-Synthelabo and NV Organon.

March 5, 2002

Phase II trial results indicate that OMS-103HP, developed for use with arthroscopy, significantly reduces postoperative pain and improves joint motion and recovery of function. The double-blind, placebo-controlled trial evaluated subjects who underwent arthroscopic anterior cruciate ligament reconstruction of the knee. In the first week following surgery, over three times as many OMS-103HP-treated subjects (compared to the control) met criteria for successful pain relief while requiring a lower total daily dose of pain medication. In terms of joint motion, 31% more OMS-103HP-treated subjects obtained at least 90 degrees of flexion without pain at repeated clinic visits. OMS-103HP is being developed by Omeros Medical Systems.