Outlook: Clinical Trials

Pharmacy Times, Volume 0, 0

Fibromyalgia Drug Meets Goal in Late-Stage Trial

A recent late-stage phase 3 trial of milnacipran, a dual-reuptake inhibitorthat preferentially blocks the reuptake of norepinephrine with higherpotency than serotonin and is currently under review by the FDA as atreatment for fibromyalgia, showed positive results and confirmed findingsfrom 2 previous phase 3 trials that show the drug improved painsymptoms in patients.

The results from the 1025-patient, multicenter, double-blind, placebo-controlledtrial showed that milnacipran demonstrated a highly statisticallysignificant difference to placebo in responder analyses based on aconcurrent and clinically meaningful improvement in pain, patient globalimpression of change, and physical functioning.

Patients were enrolled at 75 centers across North America and wererandomized to receive a daily dose of 100 mg of milnacipran (n = 516)or placebo (n = 509)?patients followed a 4- to 6-week dose-escalationphase, a 12-week stable-dose treatment phase, and a 2-week discontinuationphase. Preliminary results showed that a greater proportion ofpatients treated with milnacipran (100 mg/day) experienced at least a30% reduction in pain from baseline and also rated themselves as "verymuch 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 treatmenthas recently shown improvement.Patients taking maraviroc (Selzentry), incombination with zidovudine/lamivudine(Combivir) and selected by an enhancedsensitivity tropism test to screen patients,experienced a 68% rate of virologic suppressionto undetectable levels. These resultswere found through a reanalysis of MERITES (reanalysis of the MERIT [Maraviroc versusEfavirenz Regimens as Initial Therapy]Study with the Enhanced Trofile Assay)and were presented at the 48th AnnualInterscience Conference on AntimicrobialAgents and Chemotherapy/46th AnnualMeeting of the Infectious Diseases Societyof America in Washington, DC. In the MERITES reanalysis, 68% of patients in the maravirocarm achieved suppression of the virusto undetectable levels (<50 copies/mL).

Increased Immunity Shown with Probiotic

A recent study tested the efficacy of the probioticGanedenBC (Sustenex) in boosting the immune systemwhen exposed to adenovirus and influenza. The resultsshowed that the use of GanedenBC significantly increasedT-cell production of TNF-&#945; 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 theresponse 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 75who completed the trial. Subjects were given capsulescontaining 2 billion CFU of GanedenBC. Blood was drawn at baselineand after 30 days to measure immune response. A 250%increase was seen in the TNF-&#945; response to adenovirus, anda 1709% increase was observed in the TNF-&#945; response toinfluenza A (H3N2 Texas strain) after 30 days of treatment.

Rasagiline Slows Progression of Parkinson's Disease

The results of the phase 3 ADAGIO trialwere recently presented at the 12thCongress of European Federation ofNeurological Societies in Madrid, Spain.The study demonstrated that patientswith Parkinson's disease who began takingrasagiline (Azilect) 1-mg tablets oncedaily at the start of the trial showedsignificant improvement, compared withthose who began the drug 9 monthslater. The 1-mg dose met all 3 primaryend points and the secondary end pointwith statistical significance.

The 3 hierarchical end points of the primaryanalysis were based on total UnifiedParkinson'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 to72. The ADAGIO study?a randomized,multicenter, double-blind, placebo-controlled,parallel-group study?examinedrasagiline's potential disease-modifyingeffects on 1176 patients with very earlyParkinson?s disease in 14 countries and129 medical centers who were randomizedto receive rasagiline 1 or 2 mg/dayfor 72 weeks or placebo for 36 weeksfollowed by rasagiline 1 or 2 mg/day for36 weeks.