September 19, 2016
RespireRx Pharmaceuticals reported results of a phase IIa study of CX1739 for the respiratory depressive effects of remifentanil (REMI) and acute opioid overdose and chronic opioid use. The trial was conducted in two separate stages over a four week period. Stage 1, a randomized, double-blind, crossover study comparing 300mg of CX1739 to placebo, was considered a primary outcome study. Acute bolus injection of REMI caused a rapid and dramatic decline in respiration, with Emax ranging from 15% to 100% across subjects. When subjects in Stage 1 were pre-treated with 300mg of CX1739, a statistically significant reduction of recovery time (RT) was observed. RT was reduced from a mean of 6.8+/-0.98 after placebo pre-treatment to a mean of 4.4+/-0.77 after 300mg of CX1739 pre-treatment (p=0.01, paired t test). In Stage 2, RT was reduced for both doses, although no significant differences (p>0.05) were observed when these doses were compared to either placebo or 300mg. While this difference between 300mg and the higher doses might reflect greater efficacy at the 300mg dose, the company believes that this lack of significance for the higher doses might also reflect inter-subject variability in what doses produced the optimum decline in RT. Supporting this idea, responder analysis revealed that decreases in RT were observed, in a statistically significant proportion of subjects (13 out of 15, p<0.005, z test), after one or more doses of CX1739. Using these data from optimum doses, mean RT was significantly (p<0.002, paired t test) reduced from 6.8 +0.98 minutes after placebo to 3.7 +0.70 minutes after CX1739. Future studies are being designed and planned.
August 11, 2008
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.
September 12, 2005
Discovery Laboratories issued positive results of a phase II pilot study of their aerosolized surfactant replacement therapeutic Aerosurf, for the treatment of respiratory distress syndrome in premature infants. Study data indicated that the drug was safe and well tolerated, and encouraging preliminary observations of patient outcomes were noted: all infants survived, no incidence of lung air-leaks or necrotizing enterocolitis was noted, 15 of the 17 infants demonstrated no evidence of bronchopulmonary dysplasia at 28 days, and no incidence of peri-dosing adverse events with clinically relevant sequelae was noted. This open label, multicenter study enrolled 17 premature infants (gestational age: 28-32 weeks) across 4 sites in the US, who received Aerosurf within 30 minutes of birth for 3 hours via nasal continuous positive airway pressure.