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Foundation of America

New Medical Therapies™

Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of April 14, 2014

Alkermes released results of a phase III, randomized, multicenter, double-blind, placebo-controlled study of aripiprazole lauroxil in patients experiencing acute exacerbation of schizophrenia. A total of 623 patients were randomized to receive once-monthly intramuscular injections of aripiprazole lauroxil 441mg, aripiprazole lauroxil 882mg or placebo for 12 weeks. Patients treated once monthly with aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo (p<0.001 aripiprazole lauroxil 441mg, p<0.001 aripiprazole lauroxil 882mg), which was the prespecified primary endpoint in the study. The study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression-Improvement scale (CGI-I) versus placebo at week 12 (p<0.001). Aripiprazole lauroxil was generally well-tolerated in the phase III study, and the safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache. Based on the positive results from this study, Alkermes plans to submit a NDA to the FDA in the third quarter.

Collegium Pharmaceutical reported results of a phase II study evaluating the effect of physical manipulation by crushing Oxycodone DETERx compared with reformulated Oxy- Contin. The objective was to assess pharmacokinetics of Oxycodone DETERx when the capsule was taken intact after oral administration compared with opening the capsule and crushing the capsule contents (microspheres) prior to oral administration. These treatments were compared with OxyContin intact, OxyContin crushed and an immediate-release (IR) oxycodone tablet formulation crushed in naltrexone-blocked, healthy subjects (n=42). The study was an open label, randomized, active-controlled, five-treatment, five-period, cross-over comparison design. Crushed Oxycodone DETERx capsule contents (microspheres) (Cmax = 62.9ng/mL) were bioequivalent based upon Cmax and AUC to intact Oxycodone DETERx capsules) (Cmax = 67.5ng/mL) with similar Tmax demonstrating that crushing the contents of Oxycodone DETERx capsules did not alter the pharmacokinetics. Crushed OxyContin tablets (Cmax = 78.4ng/mL) were bioequivalent based upon Cmax and AUC to crushed IR tablets (Cmax = 79.4ng/mL), demonstrating that crushing OxyContin compromised the integrity of the time-release formulation, transforming the drug-release profile from an ER profile to an IR profile. The mean Abuse Quotient (“AQ” = Cmax/Tmax) value for crushed Oxycodone DETERx was lower than that of Oxycodone DETERx intact. The AQ for crushed OxyContin was approximately four times higher than the AQ value for OxyContin intact and similar to the crushed oxycodone IR tablets. The product’s abuse-deterrent characteristics are being evaluated in phase III trials, which have completed enrollment. The company is on track to file an NDA in Q4 of this year.

Sanofi and Regeneron Pharmaceuticals released results of a phase II study of alirocumab for the treatment of low-density lipoprotein-cholesterol (LDL-C, or “bad” cholesterol) in Japanese subjects. This multicenter, placebo-controlled, phase II study randomized approximately 100 patients with LDL-C greater than or equal to 100mg/dL receiving lipidmodifying therapy. 25 patients per group were randomized to receive one of three doses of alirocumab dosed subcutaneously every other week (Q2W)—150mg, 75mg or 50mg, or placebo, all in combination with statin therapy. At week 12, the mean percentage reduction in LDL-C from baseline in patients receiving alirocumab 5 mg Q2W was 55%, alirocumab 75mg Q2W was 62% and alirocumab 150mg Q2W was 72%, compared to 3% in the placebo group (p<0.0001 v. placebo for all treatment arms). All patients in each of the alirocumab groups achieved LDL-C levels of <100mg/dL, compared to 8% of patients in the placebo group. Treatment emergent adverse events (TEAEs) in this study were reported by 52% of patients in the alirocumab 50mg group, 48% of patients in the 75mg group, 64% of patients in the 150mg group, compared to 32% in the placebo group. The most frequently reported TEAEs were nasopharyngitis, injection site reaction, back pain, cystitis and ligament sprain.

Synta Pharmaceuticals issued interim results from a single-arm, multi-center, phase II proof-of-concept study designed to evaluate ganetespib for the treatment of metastatic breast cancer. Target enrollment is 35 patients in three cohorts, which include HER2+ breast cancer, triple-negative breast cancer (TNBC) and, recently added and now recruiting, ER/PR-positive patients previously untreated for locally advanced or metastatic disease. The goal of the trial design is to obtain initial evidence of a clinical activity signal with single-agent ganetespib administered for up to 12 weeks. Ten patients were enrolled into the HER2+ cohort and 38 patients were enrolled into the TNBC cohort. Of the patients evaluable for metabolic response based on having reached the week 3 PET assessment, six of seven achieved a metabolic response in the HER2+ cohort and 18 of 31 achieved a metabolic response in the TNBC cohort. Of the 6 HER2+ and 26 TNBC patients that reached the six-week assessment and therefore evaluable for objective RECIST response, four achieved an objective response and two achieved stable disease in the HER2+ cohort, while two achieved an objective response, 11 achieved stable disease and 13 had progressive disease in the TNBC cohort. One HER2+ patient achieved a complete objective response and has remained on treatment for over 10 months.

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