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Pharmanest released results of a phase II study of SHACT for the treatment of pain in connection with intrauterine device insertion. SHACT is a product based on a formulation of lidocaine, an anesthetic, and a proprietary application device developed to simplify topical application in the cervix and uterus. The randomized, double-blind trial involving 218 women between ages 18 and 45 showed women receiving SHACT during IUD insertion experienced a more than 30% reduction in pain, measured on a visual analogue scale, compared to patients who received placebo. This effect was statistically significant (p < 0.0001). Patients who received SHACT also experienced less discomfort (p < 0.05) than women who received placebo. Women who received SHACT reported similar adverse events, in terms of type and frequency, as women who received placebo treatment.
Cortex Pharmaceuticals reported positive results from a phase IIa trial of CX717 for the treatment of opiate-induced respiratory depression. This placebo controlled, double-blind, randomized two-way crossover trial, dubbed RD-02, enrolled 24 subjects in Europe. The subjects were placed in one of three dose groups and received either 900 mg, 1500 mg, or 2100 mg of CX717 or matching placebo, orally administered two hours before each subject received an intravenous infusion of the opiate agonist, alfentanil. The primary efficacy measures were derived from a CO2 re-breathing procedure that measured the breathing response of the subject to increased CO2 levels in the presence of alfentanil. The primary measure was the minute expiratory volume (VE) at 55mgHg CO2 (VE55). This measure was reversed by 2100 mg CX717 in comparison to placebo (p<0.03). No significant results were seen in the 900mg and 1500mg CX717 groups. Based on the data Cortex plans to move forward with the development of CX717.
Guilford Pharmaceuticals issued results of a phase III trial of their investigational sedative Aquavan (GPI-15715). Primary efficacy data met their endpoints, with 96% of subjects receiving Aquavan achieving satisfactory sedation, as measured in the study by patient performance on the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) diagnostic scale, and by the absence of need for additional sedative medication or ventilation assistance. Sedation response generally occurred within 2 minutes, with recovery from the procedure within 11 minutes. The sedation produced by Aquavan was generally observed to be deeper and longer than with midazolam, which may have contributed to the significantly higher incidence of adverse events with the drug, compared to midazolam. This randomized, open-label study enrolled 278 patients, who received treatment with Aquavan (n=209) or placebo (n=69) during elective colonoscopy. Guilford announced that, due to the high incidence of adverse events, it was suspending enrollment in all of its ongoing trials of Aquavan, pending investigation of lower-dose treatment regimens.
Manhattan Pharmaceuticals announced safety data from a phase I pilot study of their investigational sedative propofol lingual spray. These data were also to be presented at the 79th Clinical and Scientific Congress of the International Anesthesia Research Society in Honolulu, Hawaii. Preliminary safety, tolerability and pharmacokinetic data indicated that 72.7% subjects achieved measurable serum drug concentrations without incidence of adverse events, with detectable drug levels 4 minutes after dosing and a mean time to maximum blood concentration was approximately 30 minutes. This single-center, randomized, double-blind, placebo-controlled dose-escalating study enrolled 11 healthy subjects, and investigated the safety, pharmacokinetics and bioavailability of three escalating doses of the drug.
Phase I trial results indicate that Guilford Pharmaceuticals' Aquavan Injection, a water-soluble prodrug of propofol, can induce and maintain stable levels of sedation and anesthesia. The European dose-escalation phase I trial was designed to compare the pharmacokinetic and pharmacodynamic properties of propofol from Aquavan Injection versus Diprivan (propofol) Injectable Emulsion. Subjects received Diprivan as a target-controlled infusion to achieve three different plasma concentrations of propofol over a 60-minute period. Two weeks later, the subjects were administered Aquavan to achieve identical propofol concentrations. Comparable plasma concentrations of propofol were achieved in both groups; however, there was a greater decrease in the median EEG frequency for propofol from Aquavan (EC50 2 micrograms/mL), compared to Diprivan (EC50 3 micrograms/mL).