Outlook: Clinical Trials

MARCH 01, 2009

Fibromyalgia Drug Meets Goal in Late-Stage Trial

A recent late-stage phase 3 trial of milnacipran, a dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin and is currently under review by the FDA as a treatment for fibromyalgia, showed positive results and confirmed findings from 2 previous phase 3 trials that show the drug improved pain symptoms in patients.

The results from the 1025-patient, multicenter, double-blind, placebo-controlled trial showed that milnacipran demonstrated a highly statistically significant difference to placebo in responder analyses based on a concurrent and clinically meaningful improvement in pain, patient global impression of change, and physical functioning.

Patients were enrolled at 75 centers across North America and were randomized to receive a daily dose of 100 mg of milnacipran (n = 516) or placebo (n = 509)?patients followed a 4- to 6-week dose-escalation phase, a 12-week stable-dose treatment phase, and a 2-week discontinuation phase. Preliminary results showed that a greater proportion of patients treated with milnacipran (100 mg/day) experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment (P <.001).

HIV/AIDS Drug Shows Increased Efficacy

The efficacy rate for a novel HIV/AIDS treatment has recently shown improvement. Patients taking maraviroc (Selzentry), in combination with zidovudine/lamivudine (Combivir) and selected by an enhanced sensitivity tropism test to screen patients, experienced a 68% rate of virologic suppression to undetectable levels. These results were found through a reanalysis of MERIT ES (reanalysis of the MERIT [Maraviroc versus Efavirenz Regimens as Initial Therapy] Study with the Enhanced Trofile Assay) and were presented at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy/46th Annual Meeting of the Infectious Diseases Society of America in Washington, DC. In the MERIT ES reanalysis, 68% of patients in the maraviroc arm achieved suppression of the virus to undetectable levels (<50 copies/mL).

Increased Immunity Shown with Probiotic

A recent study tested the efficacy of the probiotic GanedenBC (Sustenex) in boosting the immune system when exposed to adenovirus and influenza. The results showed that the use of GanedenBC significantly increased T-cell production of TNF-α in response to adenovirus exposure (P = .027) and influenza A (H3N2 Texas strain) exposure (P = .004), but it did not have a significant effect on the response to other strains of influenza. The controlled study, conducted by Mira Baron, MD, of Rapid Medical Research, Inc, included 9 participants between the ages of 18 and 75 who completed the trial. Subjects were given capsules containing 2 billion CFU of GanedenBC. Blood was drawn at baseline and after 30 days to measure immune response. A 250% increase was seen in the TNF-α response to adenovirus, and a 1709% increase was observed in the TNF-α response to influenza A (H3N2 Texas strain) after 30 days of treatment.

Rasagiline Slows Progression of Parkinson's Disease

The results of the phase 3 ADAGIO trial were recently presented at the 12th Congress of European Federation of Neurological Societies in Madrid, Spain. The study demonstrated that patients with Parkinson's disease who began taking rasagiline (Azilect) 1-mg tablets once daily at the start of the trial showed significant improvement, compared with those who began the drug 9 months later. The 1-mg dose met all 3 primary end points and the secondary end point with statistical significance.

The 3 hierarchical end points of the primary analysis were based on total Unified Parkinson's Disease Rating Scale scores: (1) superiority of slopes in weeks 12 to 36; (2) change from baseline to week 72; and (3) noninferiority of slopes in weeks 48 to 72. The ADAGIO study?a randomized, multicenter, double-blind, placebo-controlled, parallel-group study?examined rasagiline's potential disease-modifying effects on 1176 patients with very early Parkinson?s disease in 14 countries and 129 medical centers who were randomized to receive rasagiline 1 or 2 mg/day for 72 weeks or placebo for 36 weeks followed by rasagiline 1 or 2 mg/day for 36 weeks.