Outlook: Clinical Trials

Pharmacy Times, Volume 0, 0

Ms. Farley is a freelance medical writer based in Wakefield, Rhode Island.

Budesonide for Childhood Sleep Apnea

A recent study showed that a nasalspray form of the corticosteroid budesonideimproves nighttime breathing forchildren with mild sleep apnea. Previousstudies demonstrated that intranasalcorticosteroids reduce the size of thenasal tissues in the upper airway. Whilethe treatment is usually reserved for childrenwith more severe obstructive sleepapnea, this study sought to determineeffects on children with milder apnea.The 62 study participants receivedeither a spray of budesonide or a sprayof placeboin each nostril at bedtime for6 weeks, at which time they switchedto the other treatment for 6 weeks.Children who received the budesonidesprays had significant improvementsto their quality of sleep, as well as significantreductionsin the size of theiradenoids. Study authors are encouragedby these results and hope that this datasupports "temporarily throwing awaythe scalpel" for children with mild sleepapnea. The reportappears in the July2008 issue of Pediatrics.

Osteoporosis Drug Update

A recent news release announced that Amgen's osteoporosis drug denosumabperformed well in late-stage clinical trials. After testing the drug on 1400 men overa 3-year period, researchers found that denosumab increased bone density in thelumbar spine when compared with placebo. Men who were taking denosumabalso reported fewer fractures in the vertebrae than those in the placebo group.In the company?s largest drug development venture to date, Amgen is testing thedrug in 19,000 patients who are being treated for bone cancer or cancer-relatedbone loss.

Azilect Slows PDProgression

Based on the results of the ADAGIOstudy, Teva Pharmaceuticals plans tosubmit results to regulatory authoritiesin the United States and Europe, whichcould lead to Azilect becoming the firsttreatment for Parkinson?s disease (PD)to have a label for disease modification.The ADAGIO study was a 1176-patient,randomized, multicenter, double-blind,placebo-controlled study of rasagilineand its ability to modify PD in untreatedpatients. Study participants weredivided into 2 groups: (1) the earlystartgroup that received 1 or 2 mg/day of rasagiline for 72 weeks or (2)the delayed-start group that received36 weeks of placebo followed by 36weeks of rasagiline 1 to 2 mg/day. Tevaannounced at the 12th Congress ofEuropean Federation of NeurologicalSocieties in August that Azilect slowedthe progression of PD with the 1-mgdose and met all 3 primary end points,as well as the secondary end point withstatistical significance.

Company Gears Up for 2 New Obesity Drugs

Orexigen Therapeutics is randomizingpatients for a phase 2b trial ofEmpatic (a combination of zonisamideand bupropion, both approved by theFDA)—1 of 2 obesity drugs that theyhave in the works. The trial will bea randomized, double-blind, placebo-controlledtrial of 720 generally healthy,nondiabetic obese patients at 20 USsites. For the study, patients will beplaced in 6 treatment groups, whichinclude 2 of the Empatic doses associatedwith weight loss in the previousphase 2b trial. Researchers will comparethe drug with zonisamide monotherapy,bupropion monotherapy, and placebo.Orexigen expects results in mid- tolate-2009. Results from the company'sprevious trial were highly encouragingin terms of safety and efficacy. Thosestudy results included weight loss at48 weeks ranging from 11% to 15%.Discontinuation rates were not statisticallydifferent from placebo. Orexigen'sother drug is Contrave, now in phase 3trials. The company is anticipating greatpotential in both drugs.

New Hope for Melanoma Treatment

A new drug combination of interferonalfa-2b and lovastatin from NeoPlasInnovation has stopped the progress oreradicated the tumors in at least 80% ofmelanoma patients.Although testing is in early stages,researchers point to the case of the firstperson treated with NeoPlas' protocol.Diagnosed with stage 4 melanoma anda life expectancy of only 8 weeks, thispatient was treated with the NeoPlasdrug combination and had a completeresponse, remaining disease-free for 8years. While complete eradication oftumors or long-term stability is mostcommon with this treatment, manypatients will at least see their diseaseprogression slow substantially.According to research, the drugsincluded in the combination are noteffective when administered alone, butwhen given as part of a combinationtherapy, the dosages are lower, moretolerable, and much more effective. Theunique combination works by disablingspecific abnormal cellular processes thatare typical of aggressive malignancies.Researchers are hopeful that this combinationcan be effective not only formelanoma but pancreatic cancer, coloncancer, renal cancer, mesothelioma,osteosarcoma, chondrosarcoma, andmalignant fibrous histiocytoma.