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Clinical Trials Resource Center

New Medical Therapies™

Bunion

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October 26, 2009

Pacira released positive results from a phase III trial of Exparal (DepoBupivacaine) for the reduction of pain following bunionectomy. This US-based, randomized, double-blind, parallel-group, placebo controlled study enrolled 193 subjects undergoing first metatarsal osteotomy (bunionectomy). The subjects received a single administration of Exparel or placebo following surgery and evaluated for analgesic effect. The primary endpoint, reduction in area under the curve analysis (AUC) of the numeric rating scale scores, was reached with statistical significance in the subjects receiving Exparel compared to placebo over the first 24 hours following surgery (p≡0.0005). This difference continued to be statistically significant through 36 hours. The study also met secondary endpoints with statistical significance favoring Exparel for the percentage of subjects who were pain free through 8 hours and at 48 hours; the percentage of subjects who received no rescue medication through 24 hours; and the total amount of rescue required by 24 hours. Exparel was well tolerated, with the incidence of adverse events similar to placebo.

April 27, 2009

QRxPharma reported positive results from a phase III trial of MoxDuoIR for the treatment of acute moderate to severe pain following bunionectomy surgery. This US-based, double-blind, randomized and repeated fixed-dose study enrolled 179 subjects experiencing moderate to severe pain following a scheduled bunionectomy. When post-operative pain reached a measure of at least 4 (moderate pain) on the Numerical Pain Rating Scale, subjects received either MoxDuoIR, or its individual components, morphine or oxycodone, every 6 hours for 48 hours. The primary endpoint was the achievement of pain relief for MoxDuoIR versus equivalent doses of morphine and oxycodone alone during the first 24 hours following surgery. The analgesic effects of MoxDuoIR (12mg/8mg) were 80%-100% greater than morphine or oxycodone. The MoxDuoIR (6mg/4mg) also showed similar improvements when compared to its individual components. In addition, the frequency of moderate to severe adverse events was 25% to 75% lower among the MoxDuoIR treatment group compared to the individual components. Subjects receiving morphine or oxycodone alone were two to four times more likely to prematurely discontinue dosing than those on MoxDuoIR.

November 17, 2008

Anesiva reported positive results from a phase III trial of Adlea for the treatment of pain following bunionectomy surgery. This multi-center, double-blind, placebo-controlled study, dubbed ACTIVE-1, enrolled 301 subjects in the US. The subjects were randomized to receive either a single 4 mL dose of Adlea (0.25 mg/mL) or placebo into the surgical site prior to closure. The primary endpoint, time-weighted reduction of post-surgical pain versus placebo at four to 32 hours post-surgery, narrowly missed statistical significance (p=0.07). However this measure was highly significant from four to 48 hours post-surgery (p=0.004). The trial also achieved a key secondary endpoint of reducing opioid use for Adlea versus placebo over the four to 32 hour period (p=0.012). Adverse events were similar for both active treatment and placebo groups.

May 12, 2008

QRxPharma issued positive results from a phase III trial of Q8003IR for the treatment of moderate to severe pain. This double-blind, placebo-controlled study enrolled 256 subjects with moderate to severe pain following bunionectomy, in the United States. The subjects received one of four different dosage regimens of Q8003IR or placebo over a 48 hour dosing period. Per treatment group, median doses received every four hours ranged from 3mg/2 mg to 9mg/6 mg of Q80031R. The primary endpoint was the change in pain intensity scores over the 48 hour dosing period (SPID48) in subjects receiving Q8003IR versus placebo. A strong dose-response effect in reducing pain intensity scores (SPID48) and other measures of analgesic effect were observed (p<0.001). In addition, among all Q8003IR treatment arms approximately 50% of the subjects reported good to excellent global improvement compared to 13% for placebo. Q8003IR was generally well tolerated. Based on positive phase III results QRxPharma plans to submit an NDA to the FDA in 2009.


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